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Prevention of Cardiovascular ...

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

Last Updated: 2016-01-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-12-31

Brief Summary

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Conditions

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Myocardial Infarction Cardiovascular Death Atherothrombosis Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

Oral dose twice a day

Interventions

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Ticagrelor 90 mg

Oral dose twice a day

Intervention Type DRUG

Ticagrelor 60 mg

Oral dose twice a day

Intervention Type DRUG

Ticagrelor Placebo

Oral dose twice a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugene Braunwald, MD

Role: STUDY_CHAIR

The TIMI Study Group

Marc Sabatine, MD, MPh

Role: PRINCIPAL_INVESTIGATOR

The TIMI Study Group

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United States Argentina Australia Belgium Brazil Bulgaria Canada Chile China Colombia Czechia France Germany Hungary Italy Japan Netherlands Norway Peru Philippines Poland Romania Russia Slovakia South Africa South Korea Spain Sweden Turkey (Türkiye) Ukraine United Kingdom