Coronary Disease Clinical Trial
Official title:
Prospective, Multi-centre, Randomized, Parallel Comparison to Evaluate the Safety and Efficacy of the Abluminal Sirolimus Coated Bio-engineered Stent (COMBO Stent) in Association With Short-term Single Antiplatelet Therapy in Patients With Coronary Artery Disease With an Indication for Chronic Oral Anticoagulant Therapy as Compared to a Guidelines-based Strategy
Prospective, multi-centre, randomized, open-label, parallel comparisons to evaluate
- the incidence of bleedings (COSTA-Bleed) and
- the incidence of ischemic and bleeding events (COSTA-Outcome) following a therapy with
the abluminal sirolimus coated bio-engineered stent (COMBO stent) in association with
short-term single antiplatelet therapy as compared to a guidelines-based strategy in
patients with coronary artery disease with an indication for chronic oral anticoagulant
therapy.
The COSTA trials are investigator-initiated studies aimed at comparing the clinical outcome after percutaneous coronary intervention (PCI) using a COMBO-stent based strategy associated with short-term antiplatelet therapy with a guidelines-based therapy in patients with an indication for chronic oral anticoagulation. The study is organized as a national, multi-centre prospective, randomized trial. The duration of the follow-up is 15 months. ;
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