Reveal Transition - A Mechanistic Study in Transition / Stabilized Phase of CAD

Withdrawn

• Conditions: Cardiovascular Diseases
• Interventions: Diagnostic Test: Rivaroxaban

• Registration Number: NCT04032665
• Lead Sponsor: University Hospital Tuebingen

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 disease (CAD) in the COMPASS trial. To date, there are no data comparing these - antithrombotic strategies and to provide insights about mechanistic effects of very low dose rivaroxaban on top of aspirin for longterm treatment.

Thus, the goal of the planned pilot study will be to identify effects of rivaroxaban on platelet function, platelet-mediated vascular inflammation and particularly, platelet-mediated thrombin generation as well as the underlying mechanisms and to reveal differences in mechanistic effects during longterm treatment with combined novel antiplatelet/anticoagulant strategies. This study is planned as descriptive study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-07-18
• Study Start: 2019-07-23
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-25
• Primary Completion: 2020-05
• Study Completion: 2020-05-14
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. patients≥ 18 years.
2. 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).
3. 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).
4. informed written consent.

Exclusion Criteria

1. any condition that requires longterm or already ongoing full oral anticoagulation (e.g. recent systemic embolism, prosthetic heart valves or chronic atrial fibrillation).
2. patients with increased bleeding risk preventing guideline adherent dual antiplatelet therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute coronary artery disease (ACS)	Rivaroxaban	Patients with troponin-positive ACS (NSTEMI/STEMI) with planned percutaneous coronary intervention and drug eluting stent-implantation treated with P2Y12 inhibitor (ticagrelor) and ASA
Stable coronary and peripheral artery disease (CAD/PAD)	Rivaroxaban	Stable CAD/PAD patients with previous percutaneous coronary intervention and drug eluting stent-implantation treated with dual antiplatelet therapy (ASA+clopidogrel)

Primary Outcome Measures

Name	Time	Method
Inflammation, Thrombogenicity and Mechanistic Insights During Transition from acute to chronic phase	2 years	Define the course of vascular inflammation and thrombogenicity during transition from acute to chronic phase after percutaneous coronary intervention and to provide mechanistic insights of very low dose rivaroxaban (VLDR) on platelet activation and function, platelet-triggered thrombin generation and platelet-dependent vascular inflammation. Platelet function as well as platelet-dependent vascular inflammation will be determined by flow cytometry, thrombinoscopy, spectrofluorimetry, aggregometry, total thromus-formation analysis system (T-TAS) and thrombelastography (TEG) studies

Secondary Outcome Measures

Name	Time	Method
Biomarker Expression	2 years	To reveal course of prothrombotic and inflammatory markers after acute coronary syndromes to better understand the transition from acute to stabilized phase.

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany