Comparison of different oral platelet function inhibitor treatment strategies for transitioning from the intravenous platelet function inhibitor cangrelor in patients undergoing elective percutaneous coronary interventions with coronary stent implantatio

• Conditions: Patients with obstructive coronary heart disease undergoingpercutaneous coronary stent implantation.; MedDRA version: 18.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.1Level: LLTClassification code 10069038Term: Bare metal coronary stent placementSystem Organ Class: 100000004865; MedDRA version: 18.1Level: LLTClassification code 10069037Term: Drug-eluting coronary stent placementSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005071-25-DE
• Lead Sponsor: niversity Heart Center Freiburg - Bad Krozingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-27
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

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

Inclusion Criteria

Hemodynamically 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.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Acute myocardial infarction
Treatment with P2Y12-receptor inhibitor, fibrinolysis, or GP IIb/IIIa inhibitor within 7 days before enrollment.
Contraindication for treatment with aspirin, cangrelor, clopidogrel, ticagrelor or prasugrel according to EMEA label (in particular: active bleeding, history of stroke or TIA).
Current oral anticoagulation.
Severe thrombocytopenia (< 50.000/µl).
Known severe disorder of the coagulation system.
Pregnancy or lactation.
Dementia.

Study & Design

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