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Left Ventricular ThrombusPhase 3REWARF-STEMINCT05705089

Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI

A Phase 3 study testing Rivaroxaban 15 MG and Warfarin in people with Left Ventricular Thrombus and ST Segment Elevation Myocardial Infarction, run by Rajaie Cardiovascular Medical and Research Center at 2 sites in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to assess the safety and efficacy of rivaroxaban-based versus warfarin-based antithrombotic regimens on outcomes of patients with left ventricle thrombosis following acute ST elevation myocardial infarction at 3 months from enrollment in an open-label parallel groups pilot randomized… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Rivaroxaban 15 MG and Warfarin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesIran
Study dates
30 Jul 2020to 1 Apr 2023
Phase
Phase 3
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients aged 18-80 years
  • Admission with acute STEMI in past 2 weeks
  • Acute LVT confirmed by non-contrast TTE
  • Willingness to participate and to provide a signed informed consent form

Who cannot join

  • History of the mechanical prosthetic heart valve, rheumatic heart disease, and confirmed case of antiphospholipid syndrome
  • Active bleeding
  • Cardiogenic shock defined as persistent hypotension (systolic blood pressure <90 mm Hg, or requirement of vasopressor to maintain systolic pressure >90 mm Hg) and clinical signs of hypoperfusion (cold, sweated extremities, oliguria, mental confusion, dizziness, narrow pulse pressure)
  • Acute kidney injury or chronic kidney disease with a glomerular filtration rate <30 ml/min (calculated based on the Cockcroft-Gault formula)
  • Liver failure (Child-Pugh class C)
  • Other indications for chronic anticoagulation (e.g., AF, VTE, etc.)
  • Sensitivity or intolerance to rivaroxaban/warfarin

Trial locations and contacts

2 sites in 1 country.

Iran2 sites

  • Rajaie Cardiovascular Medical and Research Center

    Tehran, 1995614331

  • Tehran Heart Center

    Tehran

Other trials in Iran

About this study

Official title: Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute ST-Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial

The purpose of the study is to assess the safety and efficacy of rivaroxaban-based versus warfarin-based antithrombotic regimens on outcomes of patients with left ventricle thrombosis following acute ST elevation myocardial infarction at 3 months from enrollment in an open-label parallel groups pilot randomized clinical trial

Read the detailed description

Direct oral anticoagulants (DOACs), are currently recognized as the first-line treatment of AF and VTE in most clinical scenarios, distinguished by their short half-life, fast onset of action, fewer medication interactions, rare food interactions, and the lack of a need for frequent laboratory monitoring, compared with vitamin K antagonists. Although the use of DOACs has earned a class III recommendation for patients with mechanical prosthetic valves, moderate-to-severe mitral stenosis, and antiphospholipid syndrome, their application in some situations, such as acute limb ischemia and LVT, remains uncertain. Until now, no completed randomized clinical trial has compared the efficacy and safety of left ventricle thrombosis in patients with acute STEMI and the existing evidence is limited to observational studies.

Being tested
Rivaroxaban 15 MG, Warfarin
Keywords
Left Ventricle, Ventricle, Left, Thrombosis, Thromboses, Blood Clot, ST Segment Elevation Myocardial Infarction, ST Elevated Myocardial Infarction, STEMI
Medical subject headings
ST Elevation Myocardial Infarction, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban 15 MGDrug

    Also called XARELTO

    Rivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))

  • WarfarinDrug

    Warfarin (to reach an INR goal of 2-2.5)+ Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))

Study groups in NCT05705089
Study groupRoleWhat they receive
Rivaroxaban-based antithrombotic regimenExperimentalAll patients assigned to the rivaroxaban-based antithrombotic regimen will receive rivaroxaban (15 mg once daily, orally) plus clopidogrel (75 mg daily, orally) plus aspirin (80 mg once daily, orally). Aspirin will be discontinued within 7 days of its initiation. The antithrombotic regimen (i.e., dual therapy) will be continued until three months after randomization.
Receives: Drug: Rivaroxaban 15 MG
warfarin-based antithrombotic regimenActive comparatorAll patients assigned to the warfarin-based antithrombotic regimen will receive warfarin (overlapping with enoxaparin until reaching an INR goal of 2-2.5) plus clopidogrel (75 mg once daily, orally) plus aspirin (80 mg once daily, orally). Aspirin will be discontinued within 7 days of its initiation. The antithrombotic regimen (i.e., dual therapy) will be continued until three months after randomization.
Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of left ventricular thrombus

    Resolution of left ventricular thrombus according to non-contrast 2D TTE performed by the imaging core laboratory, blinded to the allocation assignment

    Measured: at 3 months from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start30 Jul 2020
  3. Primary completion1 Feb 2023
  4. Study completion1 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 open-label parallel group randomized controlled trial with concealed allocation sequence and blinded outcome adjudication
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05705089
Sponsor's protocol ID
20181022041406N4
Acronym
REWARF-STEMI
Status last verified
Apr 2023
First submitted
21 Jan 2023
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jenab Y, Sadeghipour P, Mohseni-Badalabadi R, Kaviani R, Hosseini K, Pasebani Y, Khederlou H, Rafati A, Mohammadi Z, Jamalkhani S, Talasaz AHH, Firouzi A, Ariannejad H, Alemzadeh-Ansari MJ, Ahmadi-Renani S, Maadani M, Farrashi M, Bakhshandeh H, Piazza G, Krumholz HM, Mehran R, Lip GYH, Bikdeli B. Direct oral anticoagulants or warfarin in patients with left ventricular thrombus after ST-elevation myocardial infarction: a pilot trial and a prespecified meta-analysis of randomised trials. EuroIntervention. 2025 Jan 6;21(1):82-92. doi: 10.4244/EIJ-D-24-00527.

    PubMed 39773831

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban 15 MG and Warfarin in people with Left Ventricular Thrombus and ST Segment Elevation Myocardial Infarction, run by Rajaie Cardiovascular Medical and Research Center at 2 sites in Iran.

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 7 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: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Iran. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Resolution of left ventricular thrombus (time frame: at 3 months from enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05705089, which also lists 1 linked publication.

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 7 Apr 2023.

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