Comparing Rivaroxaban and Apixaban to Warfarin for Left Ventricular Clots
Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- a Clinical Trial
This study is testing whether the blood thinners rivaroxaban and apixaban are safer and more effective than warfarin for people with blood clots in the heart's left ventricle.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 141 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peshawar Institute of Cardiology Government |
| Locations | 1 site (Peshawar, KPK) |
| Trial ID | NCT05973188 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of rivaroxaban and apixaban compared to warfarin in patients with left ventricular thrombus. Participants will be randomly assigned to receive one of the three medications, and their progress will be monitored through echocardiograms at 1, 3, and 6 months to assess thrombus resolution. The study will also track adverse events, including major bleeding and stroke, to determine the overall safety of each treatment option. This research addresses the challenges associated with warfarin therapy, particularly its narrow therapeutic window and the need for frequent INR monitoring.
Who should consider this trial
Good fit: Ideal candidates for this study are hemodynamically stable patients diagnosed with left ventricular thrombus.
Not a fit: Patients with chronic liver disease, severe renal impairment, or a history of significant bleeding events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with left ventricular thrombus.
How similar studies have performed: Previous studies have shown promising results with rivaroxaban and apixaban in similar contexts, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * All hemodynamically stable patients with LV thrombus on echocardiogram after. Exclusion criteria * Chronic Liver Disease (CLD) patients * Creatinine clearance less than 15ml/min * Recent Hemorrhagic stroke * Thrombocytopenia, platelets \<50k or anemia with baseline HB \<9mg/dl * Recent Major GI bleed * History of atrial fibrillation and mitral stenosis * History of deep vein thrombosis/pulmonary embolism and Patients already on anticoagulation
Where this trial is running
Peshawar, KPK
- Peshawar Institute of Cardiology — Peshawar, Kpk, Pakistan (Recruiting)
Study contacts
- Principal investigator: Ihsan Ullah, MD — Peshawar Institute of Cardiology
- Study coordinator: Ihsan Ullah, MD
- Email: dr.ihsanulla@gmail.com
- Phone: +923365948083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.