Vienna-Resistance to Antithrombotic Therapy (REACT) - VIENNA REACT

• Conditions: Resistance to Aspirin and Clopidogrel

• Registration Number: EUCTR2007-000942-11-AT
• Lead Sponsor: Medizinische Universität Wien/ Universitätsklinik für Innere Medizin II/ Angiologie und Kardiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-17
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1100 patients requiring endovascular therapy defined as angioplasty and implantation of bare metal (BMS) or drug eluting stents for cardiovascular or peripheral arterial disease will be included in the study. According to standard clinical practice all patients undergoing angioplasty and bare metal (BMS) or drug eluting stent implantation will be treated with dual antiplatelet therapy for 3 and 12 months, respectively. 100 patients with biochemical resistance to aspirin or clopidogrel in 2 or more tests will be randomized to either 75mg or 150 mg of daily clopidogrel for 3 months after the intervention in addition to aspirin (100mg/day).
Written informed consent will be obtained from all patients.

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

Exclusion Criteria

Patients with one of the following conditions will not be included in the study:
-known aspirin or clopidogrel incompatibility,
-therapy with vitamin k antagonists (warfarin, phenprocoumon),
-history of myeloproliferative disorders or heparin-induced thrombocytopenia,
-major surgical procedure within one week before enrollment,
-a platelet count < 150.000/mcl or > 450.000/mcl and/or hemoglobin < 8g/dl,
-a family or personal history of bleeding disorder,
-malignant paraproteinemias,
-severe hepatic failure,
-lack of written informed consent,
-ingestion of ticlopidine, dipyridamole or other nonsteroidal anti-inflammatory drugs,
-known qualitative defects in thrombocyte function

Study & Design

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