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NCT03199612 · ClinicalTrials.gov registry record · Early Phase 1
Sildenafil To Prevent Clot
A Early Phase 1 study of Thrombosis and Hemolysis, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03199612 is a Early Phase 1 study of Thrombosis and Hemolysis that has completed, run by Montefiore Medical Center. The registered enrollment target is 20 participants, below the 470-participant average among 28 other Thrombosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03199612, a Early Phase 1 study of Thrombosis and Hemolysis, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The advent of continuous flow (CF) pumps for patients with severe heart failure has led to marked improvements in survival; however, pump operation remains fraught with adverse thrombotic events. This climbing rate of thrombosis and stroke during CF pump support has led to a recent warning by the US Food and Drug Administration. Despite a rising incidence of pump thrombosis and its downstream complications of stroke, the hematologic mechanisms behind these devastating adverse events remain uncertain. Recently, it has been recognized that CF pump induced hemolysis precedes and is associated with thrombosis. In-vitro studies show increased platelet function with exposure to products of hemolysis, which is also known to occur in diseases of intravascular hemolysis such as sickle cell anemia. This proposal will investigate if hemolysis associated increased platelet function can be reduced by a potentiation of nitric oxide signaling by an oral phosphodiesterase-5 inhibitor, sildenafil. Elucidating mechanisms of hemolysis induced thrombosis may inform best strategies for prevention of end organ damage and maintaining optimal CF pump operation.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Sildenafil
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2023-01-20 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03199612
The ClinicalTrials.gov registry entry for NCT03199612 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 470-participant average among 28 other Thrombosis trials with a reported enrollment target (96% lower). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Thrombosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03199612 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03199612 about?
NCT03199612 is a clinical study titled "Sildenafil To Prevent Clot". The advent of continuous flow (CF) pumps for patients with severe heart failure has led to marked improvements in survival; however, pump operation remains fraught with adverse thrombotic events. This climbing rate of thrombosis and stroke during CF pump support has led to a recent warning by the US...
What is the current status of trial NCT03199612?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2019-06-03. Estimated completion is 2023-01-20.
What conditions does trial NCT03199612 study?
This clinical trial studies the following conditions: Thrombosis, Hemolysis.
What interventions are being tested in trial NCT03199612?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Sildenafil (DRUG).
Who is sponsoring clinical trial NCT03199612?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03199612 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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