Phase 3
Completed N=21,162
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
Myocardial Infarction · Cardiovascular Death · Atherothrombosis · Stroke
Source: ClinicalTrials.gov NCT01225562 ↗
Enrolled (actual)
21,162
Serious AEs
26.4%
Results posted
Dec 2015
Primary outcomePrimary: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization — 7.8; 7.8; 9.0 Percentage of Patients — p=0.0080
Summary
This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization |
7.8; 7.8; 9.0 | 0.0080 sig |
| PRIMARY 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 |
2.6; 2.3; 1.1 | <0.0001 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization |
2.9; 2.9; 3.4 | 0.1547 |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization |
5.1; 4.7; 5.2 | 0.9851 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01225562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.