Comparison of ticagrelor and clopidogrel in patients with diabetes mellitus and ischemic heart disease

Phase 1

• Conditions: Coronary artery disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001661-27-ES
• Lead Sponsor: Sociedad Española de Cardiología

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-16
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Age between 18 and 75 years
3. Type 2 diabetes mellitus according to ADA criteria
4. Angiographically documented coronary artery disease
5. Chronic treatment (>1 month) with aspirin (100mg/day)
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Known allergies to aspirin, clopidogrel, or ticagrelor
2. Blood dyscrasia or bleeding diathesis
3. Any recent acute coronary syndrome (<30 days) or hemodinamic instability
4. Recent antiplatelet therapy (<14 days), with the exception of ASA, including: thienopyridines, cilostazol, dipiridamol, glycoprotein IIb/IIIa inhibitors
5. Oral anticoagulation with a coumarin derivative
6. Any active bleeding
7. Recent history of stroke, transient ischemic attack or intracranial bleeding (<6 months prior to inclusion)
8. Platelet count <100x106/microl
9. Any active neoplasm
10. Severe chronic kidney disease (creatinine clearance measured with Cockcroft-Gault formula <30ml/min)
11. Baseline ALT >2.5 times the upper limit of normality
12. Pregnant or childbearing females

Study & Design

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