A study to assess the effect of ticagrelor in reducing the number of days with pain in patients with sickle cell disease - Hestia2

Study identifier:D5136C00008

ClinicalTrials.gov identifier:NCT02482298

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomised, double-blind, double-dummy, parallel-group, multicenter, phase IIb study to evaluate the effect of ticagrelor versus placebo in reducing the number of days with pain in young adults with sickle cell disease

Medical condition

Sickle cell disease

Phase

Phase 2

Healthy volunteers

Study drug

Ticagrelor, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 30 Years

Date

Study Start Date: 09 Jul 2015

Primary Completion Date: 16 Nov 2016

Study Completion Date: 16 Nov 2016

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Jan 2019 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Bethesda, MD, United States, 20817

Location

Research Site

Verona, Italy, 37134

Location

Research Site

Cairo, Egypt, 11562

Location

Research Site

Alexandria, Egypt, 21131

Location

Research Site

Cairo, Egypt, 11566

Location

Research Site

Strasbourg, France, 67091

Location

Research Site

Bordeaux Cedex, France, 33076

Location

Research Site

Kisian, Kenya, 40100

Arms	Assigned Interventions
Experimental: Dose A	Drug: Ticagrelor Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.
Experimental: Dose B	Drug: Ticagrelor Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.
Placebo Comparator: Placebo	Drug: Placebo 10 mg ticagrelor placebo + 45 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening at least 12 hours apart) from randomization until the end of treatment

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 26 centers in 8 countries between 09 July 2015 and 16 November 2016.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study duration was approximately 18 weeks, consisting of a screening period including a 4-week single-blind placebo treatment for baseline assessments, a 12-week double-blind randomised treatment period, and a 2-week follow-up period. A total of 87 patients were randomized

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID

Participant Flow: Overall Study

	PLACEBO 10MG BID + PLACEBO 45MG BID	TICAGRELOR 10MG BID + PLACEBO 45MG BID	TICAGRELOR 45MG BID + PLACEBO 10MG BID
STARTED	30	27	30
COMPLETED	28	24	27
NOT COMPLETED	2	3	3
Withdrawal by Subject	2	1	2
Did Not Fulfill Randomization Criteria	0	1	0
Dev. of Study-Spec. Withdrawal Criteria	0	0	1
Lost to Follow-up	0	1	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID

Baseline Measures

	PLACEBO 10MG BID + PLACEBO 45MG BID	TICAGRELOR 10MG BID + PLACEBO 45MG BID	TICAGRELOR 45MG BID + PLACEBO 10MG BID	Total
Number of Participants [units: Participants]	30	27	30	87
Age Continuous [units: Years] Mean ± Standard Deviation	21.6 ± 3.42	21.9 ± 2.72	23.2 ± 3.69	22.2 ± 3.35
Gender, Male/Female [units: ]
Female	16	15	16	47
Male	14	12	14	40
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	15	14	17	46
White	15	12	13	40
More than one race	0	1	0	1
Unknown or Not Reported	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Change in proportion of days with pain due to sickle cell disease as measured by an eDiary [ Time Frame: Baseline through Week 12 ]

Measure Type	Primary
Measure Name	Change in proportion of days with pain due to sickle cell disease as measured by an eDiary
Measure Description	To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.
Time Frame	Baseline through Week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID

Measured Values

	PLACEBO 10MG BID + PLACEBO 45MG BID	TICAGRELOR 10MG BID + PLACEBO 45MG BID	TICAGRELOR 45MG BID + PLACEBO 10MG BID
Number of Participants Analyzed [units:participants]	30	27	30
Change in proportion of days with pain due to sickle cell disease as measured by an eDiary [units: Proportion of days with pain] Least Squares Mean (90% Confidence Interval)	-0.1802 (-0.2673 to -0.0931)	-0.1352 (-0.2260 to -0.0444)	-0.1001 (-0.1881 to -0.0121)

Statistical Analysis 1 for Change in proportion of days with pain due to sickle cell disease as measured by an eDiary

Groups^[1]	PLACEBO 10MG BID + PLACEBO 45MG BID, TICAGRELOR 10MG BID + PLACEBO 45MG BID
Method^[3]	Mixed Models Analysis
Mean Difference (Final Values)^[5]	0.0450
Standard Error of the mean	± 0.06367
90% Confidence Interval	( -0.0610 to 0.1510 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change in proportion of days with pain due to sickle cell disease as measured by an eDiary

Groups^[1]	PLACEBO 10MG BID + PLACEBO 45MG BID, TICAGRELOR 45MG BID + PLACEBO 10MG BID
Method^[3]	Mixed Models Analysis
Mean Difference (Final Values)^[5]	0.0801
Standard Error of the mean	± 0.06192
90% Confidence Interval	( -0.0230 to 0.1832 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: Average of the daily worst pain values reported via eDiary [ Time Frame: Baseline through Week 12 ]

Measure Type	Secondary
Measure Name	Average of the daily worst pain values reported via eDiary
Measure Description	To determine the efficacy of 2 different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease. Intensity of pain was recorded on an 11-point scale where 0 represented no pain and 10 represented the worst pain imaginable.
Time Frame	Baseline through Week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID

Measured Values

	PLACEBO 10MG BID + PLACEBO 45MG BID	TICAGRELOR 10MG BID + PLACEBO 45MG BID	TICAGRELOR 45MG BID + PLACEBO 10MG BID
Number of Participants Analyzed [units:participants]	30	27	30
Average of the daily worst pain values reported via eDiary [units: Average daily worst pain rating] Mean (Standard Deviation)	1.02 (1.106)	1.15 (1.547)	1.74 (2.277)

No statistical analysis provided for Average of the daily worst pain values reported via eDiary

3. Secondary Outcome Measure: Change in proportion of days with analgesic use measured by an eDiary [ Time Frame: Baseline through Week 12 ]

Measure Type	Secondary
Measure Name	Change in proportion of days with analgesic use measured by an eDiary
Measure Description	To assess the efficacy of 2 different doses of ticagrelor versus placebo in reducing the use of analgesics by patients with sickle cell disease.
Time Frame	Baseline through Week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID

Measured Values

	PLACEBO 10MG BID + PLACEBO 45MG BID	TICAGRELOR 10MG BID + PLACEBO 45MG BID	TICAGRELOR 45MG BID + PLACEBO 10MG BID
Number of Participants Analyzed [units:participants]	30	27	30
Change in proportion of days with analgesic use measured by an eDiary [units: Proportion of days with analgesic use] Least Squares Mean (90% Confidence Interval)	-0.1991 (-0.2753 to -0.1230)	-0.0799 (-0.1590 to -0.0008)	-0.1016 (-0.1782 to -0.0250)

Statistical Analysis 1 for Change in proportion of days with analgesic use measured by an eDiary

Groups^[1]	PLACEBO 10MG BID + PLACEBO 45MG BID, TICAGRELOR 10MG BID + PLACEBO 45MG BID
Method^[3]	Mixed Models Analysis
Mean Difference (Final Values)^[5]	0.1192
Standard Error of the mean	± 0.05059
90% Confidence Interval	( 0.0350 to 0.2035 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change in proportion of days with analgesic use measured by an eDiary

Groups^[1]	PLACEBO 10MG BID + PLACEBO 45MG BID, TICAGRELOR 45MG BID + PLACEBO 10MG BID
Method^[3]	Mixed Models Analysis
Mean Difference (Final Values)^[5]	0.0975
Standard Error of the mean	± 0.04923
90% Confidence Interval	( 0.0155 to 0.1795 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Other Pre-specified Outcome Measure: Number of major bleeding or clinically relevant non-major bleeding events (patients) [ Time Frame: Baseline through Week 12 ]

Measure Type	Other Pre-specified
Measure Name	Number of major bleeding or clinically relevant non-major bleeding events (patients)
Measure Description	To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD
Time Frame	Baseline through Week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety analysis set included all patients who received at least 1 single dose of randomised IP, ticagrelor or placebo, and for whom any post-dose data were available. Patients were analysed according to the actual treatment.

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID

Measured Values

	PLACEBO 10MG BID + PLACEBO 45MG BID	TICAGRELOR 10MG BID + PLACEBO 45MG BID	TICAGRELOR 45MG BID + PLACEBO 10MG BID
Number of Participants Analyzed [units:participants]	30	26	30
Number of major bleeding or clinically relevant non-major bleeding events (patients) [units: Number of patients]
Patients with any bleeding events	2	2	2
Pts w/ any bleeding event requiring intervention	2	1	2

No statistical analysis provided for Number of major bleeding or clinically relevant non-major bleeding events (patients)

5. Other Pre-specified Outcome Measure: Number of major bleeding or clinically relevant non-major bleeding events (events) [ Time Frame: Baseline through Week 12 ]

Measure Type	Other Pre-specified
Measure Name	Number of major bleeding or clinically relevant non-major bleeding events (events)
Measure Description	To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD
Time Frame	Baseline through Week 12
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety analysis set included all patients who received at least 1 single dose of randomised IP, ticagrelor or placebo, and for whom any post-dose data were available. Patients were analysed according to the actual treatment.

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID

Measured Values

	PLACEBO 10MG BID + PLACEBO 45MG BID	TICAGRELOR 10MG BID + PLACEBO 45MG BID	TICAGRELOR 45MG BID + PLACEBO 10MG BID
Number of Participants Analyzed [units:participants]	30	26	30
Number of major bleeding or clinically relevant non-major bleeding events (events) [units: Number of events]
Total number of bleeding events	2	2	2
Maximum severity of bleeding event: Minor	0	1	0
Max sever. of bleed event: Clin-relevant nonmajor	2	1	2
Maximum severity of bleeding event: Major	0	0	0

No statistical analysis provided for Number of major bleeding or clinically relevant non-major bleeding events (events)

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID	No text entered.
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID	No text entered.

Serious Adverse Events

PLACEBO 10MG BID + PLACEBO 45MG BID

TICAGRELOR 10MG BID + PLACEBO 45MG BID

TICAGRELOR 45MG BID + PLACEBO 10MG BID

Total, serious adverse events

# participants affected / at risk

6/30 (20.00%)

6/26 (23.08%)

5/30 (16.67%)

Blood and lymphatic system disorders

Reticulocytopenia¹,^†

# participants affected / at risk

0/30 (0.00%)

0/26 (0.00%)

1/30 (3.33%)

# events

Blood and lymphatic system disorders

Sickle cell anaemia with crisis¹,^†

# participants affected / at risk

3/30 (10.00%)

5/26 (19.23%)

3/30 (10.00%)

# events

General disorders and administration site conditions

Local swelling¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

0/30 (0.00%)

# events

Hepatobiliary disorders

Hepatic ischaemia¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

0/30 (0.00%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

0/30 (0.00%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

2/30 (6.67%)

0/26 (0.00%)

1/30 (3.33%)

# events

Infections and infestations

Lower respiratory tract infection¹,^†

# participants affected / at risk

0/30 (0.00%)

1/26 (3.85%)

0/30 (0.00%)

# events

Injury, poisoning and procedural complications

Face injury¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

0/30 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

0/30 (0.00%)

1/26 (3.85%)

0/30 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

0/30 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

0/30 (0.00%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

0/30 (0.00%)

1/26 (3.85%)

0/30 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Acute chest syndrome¹,^†

# participants affected / at risk

0/30 (0.00%)

1/26 (3.85%)

1/30 (3.33%)

# events

Vascular disorders

Vascular occlusion¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

0/30 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 19.0

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
PLACEBO 10MG BID + PLACEBO 45MG BID	No text entered.
TICAGRELOR 10MG BID + PLACEBO 45MG BID	Note that 1 patient in the Ticagrelor 10mg BID + Placebo 45mg BID group was excluded from the Safety analysis set because they had no post-dose assessments.
TICAGRELOR 45MG BID + PLACEBO 10MG BID	No text entered.

Other Adverse Events

PLACEBO 10MG BID + PLACEBO 45MG BID

TICAGRELOR 10MG BID + PLACEBO 45MG BID

TICAGRELOR 45MG BID + PLACEBO 10MG BID

Total, other (not including serious) adverse events

# participants affected / at risk

16/30 (53.33%)

15/26 (57.69%)

20/30 (66.67%)

Blood and lymphatic system disorders

Sickle cell anaemia with crisis¹,^†

# participants affected / at risk

1/30 (3.33%)

1/26 (3.85%)

2/30 (6.67%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

3/30 (10.00%)

5/26 (19.23%)

3/30 (10.00%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

1/30 (3.33%)

1/26 (3.85%)

3/30 (10.00%)

# events

Gastrointestinal disorders

Toothache¹,^†

# participants affected / at risk

1/30 (3.33%)

2/26 (7.69%)

0/30 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

1/30 (3.33%)

2/26 (7.69%)

2/30 (6.67%)

# events

General disorders and administration site conditions

Fatigue¹,^†

# participants affected / at risk

2/30 (6.67%)

1/26 (3.85%)

2/30 (6.67%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

3/30 (10.00%)

3/26 (11.54%)

4/30 (13.33%)

# events

General disorders and administration site conditions

Pain¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

2/30 (6.67%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

2/30 (6.67%)

2/26 (7.69%)

4/30 (13.33%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

4/30 (13.33%)

1/26 (3.85%)

1/30 (3.33%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

4/30 (13.33%)

2/26 (7.69%)

2/30 (6.67%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

6/30 (20.00%)

6/26 (23.08%)

9/30 (30.00%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

7/30 (23.33%)

4/26 (15.38%)

4/30 (13.33%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹,^†

# participants affected / at risk

0/30 (0.00%)

1/26 (3.85%)

2/30 (6.67%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹,^†

# participants affected / at risk

2/30 (6.67%)

3/26 (11.54%)

3/30 (10.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

5/30 (16.67%)

4/26 (15.38%)

9/30 (30.00%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

8/30 (26.67%)

11/26 (42.31%)

8/30 (26.67%)

# events

Reproductive system and breast disorders

Dysmenorrhoea¹,^†

# participants affected / at risk

0/30 (0.00%)

1/26 (3.85%)

2/30 (6.67%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

0/30 (0.00%)

2/26 (7.69%)

0/30 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Epistaxis¹,^†

# participants affected / at risk

1/30 (3.33%)

0/26 (0.00%)

2/30 (6.67%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹,^†

# participants affected / at risk

2/30 (6.67%)

2/26 (7.69%)

1/30 (3.33%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 19.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Public disclosure of trial results by Principle Investigators within two years of trial completion requires Sponsor’s prior written consent.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Brilinta Global Clinical Leader
Organization:	AstraZeneca
Phone	+46 31 776 10 00

Documents available

D5136c00008 revised csp redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Maria Ignacia -Berraondo

Quintiles, Inc.

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

D5136c00008 revised csp redacted

Trial Results Summaries