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

NCT ID: NCT05705089

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2023-04-01

Brief 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 clinical trial

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.

Conditions

Left Ventricular Thrombus; ST Segment Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rivaroxaban-based antithrombotic regimen

All 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.

Group Type: EXPERIMENTAL

Rivaroxaban 15 MG

Intervention Type: DRUG

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

warfarin-based antithrombotic regimen

All 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.

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

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))

Interventions

Rivaroxaban 15 MG

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

Intervention Type: DRUG

Warfarin

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))

Intervention Type: DRUG

Other Intervention Names

XARELTO

Eligibility Criteria

Inclusion Criteria

1. Adult patients aged 18-80 years

2. Admission with acute STEMI in past 2 weeks

3. Acute LVT confirmed by non-contrast TTE

4. Willingness to participate and to provide a signed informed consent form

Exclusion Criteria

1. History of the mechanical prosthetic heart valve, rheumatic heart disease, and confirmed case of antiphospholipid syndrome

2. Active bleeding

3. 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)

4. Acute kidney injury or chronic kidney disease with a glomerular filtration rate <30 ml/min (calculated based on the Cockcroft-Gault formula)

5. Liver failure (Child-Pugh class C)

6. Other indications for chronic anticoagulation (e.g., AF, VTE, etc.)

7. Sensitivity or intolerance to rivaroxaban/warfarin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran Heart Center

OTHER

Sponsor Role: collaborator

Rajaie Cardiovascular Medical and Research Center

OTHER

Sponsor Role: lead

Responsible Party

Parham Sadeghipour

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parham Sadeghipour, M.D

Role: PRINCIPAL_INVESTIGATOR

Rajaie Cardiovascular Medical and Research Center

Locations

Rajaie Cardiovascular Medical and Research Center

Tehran, , Iran

Tehran Heart Center

Tehran, , Iran

Countries

Iran

References

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.

Reference Type: DERIVED

PMID: 39773831 (View on PubMed)

Other Identifiers

20181022041406N4

Identifier Type: -

Identifier Source: org_study_id