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

NCT04032665 | Withdrawn

• 1 other identifier: Reveal Transition
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Inflammation, Thrombogenicity and Mechanistic Insights During Transition from acute to chronic phase

  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

  2 years

Secondary Outcomes (1)

• Biomarker Expression

  2 years

Study Arms (2)

Stable coronary and peripheral artery disease (CAD/PAD)

Stable CAD/PAD patients with previous percutaneous coronary intervention and drug eluting stent-implantation treated with dual antiplatelet therapy (ASA+clopidogrel)

Diagnostic Test: Rivaroxaban

Acute coronary artery disease (ACS)

Patients with troponin-positive ACS (NSTEMI/STEMI) with planned percutaneous coronary intervention and drug eluting stent-implantation treated with P2Y12 inhibitor (ticagrelor) and ASA

Diagnostic Test: Rivaroxaban

Interventions

Rivaroxaban DIAGNOSTIC_TEST

In stable CAD/PAD patients with previous PCI and DES-implantation treated with DAPT (ASA+clopidogrel) platelet rich plasma (PRP) and washed platelets as well as serum/plasma/urinary samples will be collected between 2 and 4 weeks before switching from DAPT to ASA + rivaroxaban (2,5 mg b.i.d.), between 2 and 4 weeks under monotherapy with ASA 100mg o.d., and between 2 and 4 weeks under therapy with ASA 100mg o.d. + rivaroxaban (2,5 mg b.i.d.) and treated ex vivo with rivaroxaban to asses platelet activation and function, platelet-triggered thrombin generation and platelet-dependent vascular inflammation.

Acute coronary artery disease (ACS); Stable coronary and peripheral artery disease (CAD/PAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients post troponin-positive acute coronary syndromes (STEMI n=17 + NSTEMI n=17) or stable CAD + peripheral artery disease (PAD) (n=17) with additional risk factors (see inclusion cirteria) who underwent PCI.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Bayer: collaborator

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Tobias Geisler, Professor

  University Hospital of Tuebingen

  PRINCIPAL INVESTIGATOR

• Oliver Alexander Borst, Professor

  University Hospital of Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 25, 2019
• Study Start: July 23, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 14, 2020
• Last Updated: July 18, 2022

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)