Status:
WITHDRAWN
Reveal Transition - A Mechanistic Study in Transition / Stabilized Phase of CAD
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Bayer
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Longterm oral anticoagulation with very low dose rivaroxaban (2.5mg bid) in combination with aspirin has been shown superior over standard aspirin monotherapy in patients with stable coronary artery d...
Eligibility Criteria
Inclusion
- patients≥ 18 years.
- troponin-positive acute coronary syndrome (NSTEMI/STEMI) with planned dual antiplatelet therapy (DAPT, ASA + ticagrelor) for 12 months or stable CAD with previous PCI and drug eluting-stent (DES) + pre-existing PAD under treatment with DAPT (ASA + clopidogrel).
- Patients with coronary artery disease who are younger than 65 years of age are required to have documentation of atherosclerosis involving at least two vascular beds or to have at least two additional risk factors (current smoking, diabetes mellitus, an estimated glomerular filtration rate \[GFR\] \<60 ml per minute, heart failure, or nonlacunar ischemic stroke ≥1 month earlier).
- informed written consent.
Exclusion
- any condition that requires longterm or already ongoing full oral anticoagulation (e.g. recent systemic embolism, prosthetic heart valves or chronic atrial fibrillation).
- patients with increased bleeding risk preventing guideline adherent dual antiplatelet therapy
Key Trial Info
Start Date :
July 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 14 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04032665
Start Date
July 23 2019
End Date
May 14 2020
Last Update
July 18 2022
Active Locations (1)
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1
University Hospital Tuebingen
Tübingen, Germany, 72076