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 INFARCTIO

Not Applicable

• Conditions: -I25; I25

• Registration Number: PER-102-10
• Lead Sponsor: ASTRAZENECA PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified