drugset / Trial / NCT02723981

COMBO-Stent in Patients on Chronic Anticoagulant Therapy (COSTA) COSTA-Bleed and COSTA-Outcome Trials

NCT02723981 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-04
Primary completion
2018-05
Completion
2018-12

Outcome

Outcome not reported

Stopped: “Regulatory authority approval for the initial study design could not be obtained”

Drugs

EvaluationDrugModalityDoseRoute
Comparator ASA Unknown — —
Subject Clopidogrel Small molecule — —
Background Dabigatran Unknown — —
Background Phenprocoumon Small molecule — —
Background Rivaroxaban Other / unclassified — —