Reveal Transition - A Mechanistic Study in Transition / Stabilized Phase of CAD
NCT ID: NCT04032665
Last Updated: 2022-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2019-07-23
2020-05-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. patients with increased bleeding risk preventing guideline adherent dual antiplatelet therapy
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Tobias Geisler, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Tuebingen
Oliver Alexander Borst, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Tuebingen
Locations
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University Hospital Tuebingen
Tübingen, , Germany
Countries
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Other Identifiers
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Reveal Transition
Identifier Type: -
Identifier Source: org_study_id
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