A comparative study of platelet inhibition between thelower ticagrelor and prasugrel doses in patients with prior myocardialinfarctio

Phase 1

• Conditions: In this study we aim to compare the platelet inhibition of 60mg ticagrelor bid versus 5mg prasugrel in patients with prior myocardial infarction within previous 1-3 years; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004959-80-GR
• Lead Sponsor: Special Account For Research Funds- National and Capodistrian University of Athens

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-14
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Post- menopausal female
3. A spontaneous myocardial infarction 1 to 3 years before enrollment and at least 50 years of age. In addition, at least one of the following high-risk features: age of 65 years or older, diabetes mellitus requiring medication, a second prior spontaneous MI, multivessel coronary artery disease, or chronic renal dysfunction, (estimated creatinine clearance of <60 ml per minute).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Planned use of a P2Y12 receptor antagonist, dipyridamole, cilostazol, or anticoagulant therapy during the study period
2. Known allergy to ticagrelor or prasugrel or any excipients
3. A bleeding disorder or a history of an ischemic stroke or intracranial bleeding, a central nervous system tumor, or an intracranial vascular abnormality
4. Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified