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

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ClinicalTrials.gov Identifier: NCT04032665
Recruitment Status : Enrolling by invitation
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Cardiovascular Diseases Diagnostic Test: Rivaroxaban

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reveal Transition: Rivaroxaban-Evaluation of Variables Enhancing Antithrombotic Efficacy and Longterm-Outcome in Stabilized Patients With Cardiovascular Disease. A Mechanistic Study in Transition / Stabilized Phase of CAD
Estimated Study Start Date : July 23, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
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
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)
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
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.




Primary Outcome Measures :
  1. Inflammation, Thrombogenicity and Mechanistic Insights During Transition from acute to chronic phase [ Time Frame: 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 :
  1. Biomarker Expression [ Time Frame: 2 years ]
    To reveal course of prothrombotic and inflammatory markers after acute coronary syndromes to better understand the transition from acute to stabilized phase.


Biospecimen Retention:   Samples Without DNA
Blood and urine samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032665


Locations
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Germany
University Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Bayer
Investigators
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Principal Investigator: Tobias Geisler, Professor University Hospital of Tuebingen
Principal Investigator: Oliver Alexander Borst, Professor University Hospital of Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04032665     History of Changes
Other Study ID Numbers: Reveal Transition
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants