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Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT)
Left ventricular (LV) thrombus is a common problem that is encountered in patients who survived from a large myocardial infarction, and distal systemic embolization is the main issue in these patients due to its major clinical consequences especially cerebrovascular stroke.
Novel oral anticoagulants (NOACs) are now used safely in nonvalvular atrial fibrillation, these agents were shown to be at least as effective as Vitamin K antagonists (VKA) such as warfarin in prevention of systemic embolism, while having an improved safety profile with less bleeding risk. However, the data about their usage for LV thrombi instead of the commonly used VKA are still lacking except for case reports and small case series.
The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anticoagulants; Increased Left Ventricular Thrombosis | Drug: Rivaroxaban 20 MG Drug: Warfarin Sodium | Phase 3 |
The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.
So patients with actual LV thrombus will be divided into 2 groups, one will receive the traditional therapy which is warfarin with follow up of the INR in order to reach the desired level of 2-3 then follow up every two weeks to determine the time in therapeutic range until the end of the study follow up. The other group will receive oral rivaroxaban 20 mg per day with follow up for the persistence or the disappearance of the LV thrombus one month, three months and 6 months later.
As a secondary and safety end point, any major bleeding will be recorded as well as any thrombo-embolic events
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 79 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi |
| Actual Study Start Date : | December 1, 2018 |
| Actual Primary Completion Date : | May 1, 2020 |
| Actual Study Completion Date : | May 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Warfarin
38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive warfarin by the regular starting dose with follow up of the INR to target (2-3)
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Drug: Warfarin Sodium
38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive warfarin sodium by a dose starting from 3 mg per day and titrated accordingly to target an INR of 2-3
Other Name: Marevan
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Experimental: Rivaroxaban
38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive rivaroxaban in a dose of 20 mg per day
|
Drug: Rivaroxaban 20 MG
38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive rivaroxaban 20 mg per day
Other Name: Xarelto
|
- Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography [ Time Frame: 1 month ]2D transthoracic echocardiography will be done after 1 month of initiation of the anticoagulant in order to assess the presence/absence of the thrombus
- Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography [ Time Frame: 3 months ]2D transthoracic echocardiography will be done after 3 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus
- Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography [ Time Frame: 6 months ]2D transthoracic echocardiography will be done after 6 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus
- Stroke or systemic embolism [ Time Frame: Up to 6 months ]Any type of stroke or systemic embolism event will be recorded
- Major bleeding [ Time Frame: Up to 6 months ]Any major bleeding that may occur according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH) will be recorded
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE).
Exclusion Criteria:
- Creatinine clearance less than 50 ml/min.
| Egypt | |
| Andalusia Hospitals | |
| Alexandria, Egypt, 21524 | |
| Study Director: | Haitham Badran, PhD | Assisstant Professor of Cardiology and Angiology, University of Ain Shams, Egypt |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 21, 2019 | ||||||
| First Posted Date ICMJE | April 24, 2019 | ||||||
| Last Update Posted Date | June 11, 2020 | ||||||
| Actual Study Start Date ICMJE | December 1, 2018 | ||||||
| Actual Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Presence and dimensions of left ventricular thrombus as assessed by 2D transthoracic echocardiography [ Time Frame: 3 months ] 2D transthoracic echocardiography will be done after 3 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus and its size and dimensions if still present
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi | ||||||
| Official Title ICMJE | Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi | ||||||
| Brief Summary |
Left ventricular (LV) thrombus is a common problem that is encountered in patients who survived from a large myocardial infarction, and distal systemic embolization is the main issue in these patients due to its major clinical consequences especially cerebrovascular stroke. Novel oral anticoagulants (NOACs) are now used safely in nonvalvular atrial fibrillation, these agents were shown to be at least as effective as Vitamin K antagonists (VKA) such as warfarin in prevention of systemic embolism, while having an improved safety profile with less bleeding risk. However, the data about their usage for LV thrombi instead of the commonly used VKA are still lacking except for case reports and small case series. The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus. |
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| Detailed Description |
The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus. So patients with actual LV thrombus will be divided into 2 groups, one will receive the traditional therapy which is warfarin with follow up of the INR in order to reach the desired level of 2-3 then follow up every two weeks to determine the time in therapeutic range until the end of the study follow up. The other group will receive oral rivaroxaban 20 mg per day with follow up for the persistence or the disappearance of the LV thrombus one month, three months and 6 months later. As a secondary and safety end point, any major bleeding will be recorded as well as any thrombo-embolic events |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
79 | ||||||
| Original Estimated Enrollment ICMJE |
60 | ||||||
| Actual Study Completion Date ICMJE | May 1, 2020 | ||||||
| Actual Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Egypt | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03926780 | ||||||
| Other Study ID Numbers ICMJE | YIG01201903 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Abdallah Almaghraby, The Young Investigator Group of Cardiovascular Research | ||||||
| Study Sponsor ICMJE | The Young Investigator Group of Cardiovascular Research | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | The Young Investigator Group of Cardiovascular Research | ||||||
| Verification Date | June 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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