Pharmacodynamic comparison of thienopyridine loading strategies in patients undergoing elective coronary stenting

Phase 3

• Conditions: I25; Chronic ischaemic heart disease

• Registration Number: DRKS00006102
• Lead Sponsor: niversitäts-Herzzentrum Freiburg - Bad Krozingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-21
• Study Completion: 2015-03-31
• Results First Posted: 2016-02-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Stable patients with obstructive coronary heart disease and planned coronary stent implantation.
Pretreatment with aspirin (100mg daily or loading dose of 400mg before coronary angiography).
Age >= 18 years.
Written informed consent.

Exclusion Criteria

Acute myocardial infarction
Treatment with ticagrelor, prasugrel, fibrinolysis, or GP IIb/IIIa inhibitor within 7 days before enrollment.
Contraindication for treatment with aspirin, clopidogrel, or prasugrel (in particular: active bleeding, history of stroke or TIA).
Current oral anticoagulation.
Severe thrombocytopenia (< 50.000/µl).
Known severe disorder of the coagulation system.
Participation in another drug trial.
Pregnancy or lactation.
Persons with a state of dependence with sponsor or investigator.
Commitment to an institution.
Dementia or other psychatric disorder (e.g., drug abuse) that prevents sufficient informed consent.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with ADP-induced platelet aggregation < 468 AU x min tested 1 hour following loading dose

Secondary Outcome Measures

Name	Time	Method
Absolute ADP-induced platelet aggregation tested 0.5, 1.0, 1.5, 2.0, and 3.0 hours and day 1 following loading dose<br>Proportion of patients with ADP-induced platelet aggregation < 468 AU x min tested 2, 3 hours and day 1 following loading dose<br>Proportion of patients with ADP-induced platelet aggregation > 188 and < 468 AU x min tested 1, 2, 3 hours and day 1 following loading dose<br>Ischemic and bleeding events within 4 weeks after inclusion (death, myocardial infarction, revascularization, stroke, bleeding according to BARC Criteria).