Cardiovascular DiseasesRevealTransNCT04032665
Reveal Transition - A Mechanistic Study in Transition / Stabilized Phase of CAD
An observational study of Cardiovascular Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Rivaroxaban
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jul 2019to 14 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Rivaroxaban
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Diagnostic Test: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Biomarker Expression
To reveal course of prothrombotic and inflammatory markers after acute coronary syndromes to better understand the transition from acute to stabilized phase.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start23 Jul 2019
- Primary completionMay 2020 (estimated)
- Study completion14 May 2020
Why it stopped: study design reconsidered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Tobias Geisler, Professor, Principal investigator, University Hospital of TuebingenOliver Alexander Borst, Professor, Principal investigator, University Hospital of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032665
- Sponsor's protocol ID
- Reveal Transition
- Acronym
- RevealTrans
- Status last verified
- Jun 2019
- First submitted
- 18 Jul 2019
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04032665
- Acronym / sponsor ID
- RevealTrans / Reveal Transition
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study design reconsidered
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- 14 May 2020 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable coronary and peripheral artery disease (CAD/PAD) | – | Diagnostic Test: RivaroxabanStable CAD/PAD patients with previous percutaneous coronary intervention and drug eluting stent-implantation treated with dual antiplatelet therapy (ASA+clopidogrel) |
| Acute coronary artery disease (ACS) | – | Diagnostic Test: RivaroxabanPatients with troponin-positive ACS (NSTEMI/STEMI) with planned percutaneous coronary intervention and drug eluting stent-implantation treated with P2Y12 inhibitor (ticagrelor) and ASA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanIn 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. | Diagnostic test | Acute coronary artery disease (ACS), Stable coronary and peripheral artery disease (CAD/PAD) |
Primary outcome
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
1 secondary outcome
Biomarker Expression
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Geisler, Professor principal investigator
University Hospital of Tuebingen
Oliver Alexander Borst, Professor principal investigator
University Hospital of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation, Thrombogenicity and Mechanistic Insights During Transition from acute to chronic phase (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.