Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin (PEGASUS)
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ClinicalTrials.gov Identifier: NCT01225562 |
Recruitment Status
:
Completed
First Posted
: October 21, 2010
Results First Posted
: December 9, 2015
Last Update Posted
: January 25, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Cardiovascular Death Atherothrombosis Stroke | Drug: Ticagrelor 90 mg Drug: Ticagrelor 60 mg Drug: Ticagrelor Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21379 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Oral Treatment
|
Drug: Ticagrelor 90 mg
Oral dose twice a day
|
Experimental: 2
Oral Treatment
|
Drug: Ticagrelor 60 mg
Oral dose twice a day
|
Placebo Comparator: 3
Oral Treatment
|
Drug: Ticagrelor Placebo
Oral dose twice a day
|
- Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization [ Time Frame: Randomization up to 47 months ]Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
- Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients [ Time Frame: First dosing up to 48 months ]A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug
- Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization [ Time Frame: Randomization up to 47 months ]Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization
- Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization [ Time Frame: Randomization up to 47 months ]Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization

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Ages Eligible for Study: | 50 Years to 130 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Person who had a heart attack within 1 - 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
- Females of child-bearing potential must have a negative pregnancy test at enrollment
- Persons who are currently taking aspirin between 75 and 150 mg once daily
Exclusion Criteria:
- Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start
- Persons who have planned coronary, cerebrovascular, or peripheral arterial Revascularization (invasive surgery) at study start
- Persons with known bleeding disorders
- Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
- Persons with a history of ischemic stroke
- Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
- Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker
- Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery
- Persons with known severe liver disease
- Persons with kidney failure requiring dialysis
- Persons with life expectancy < 1 year

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225562

Study Chair: | Eugene Braunwald, MD | TIMI Study Group | |
Principal Investigator: | Marc Sabatine, MD, MPh | TIMI Study Group |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01225562 History of Changes |
Other Study ID Numbers: |
D5132C00001 2009-017242-30 ( EudraCT Number ) |
First Posted: | October 21, 2010 Key Record Dates |
Results First Posted: | December 9, 2015 |
Last Update Posted: | January 25, 2016 |
Last Verified: | December 2015 |
Keywords provided by AstraZeneca:
Heart attack Heart Disease Acute coronary syndrome ACS Cardiovascular Disease |
Additional relevant MeSH terms:
Stroke Infarction Myocardial Infarction Death Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Ticagrelor Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |