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Phosphodiesterase-5 Inhibitor
Sildenafil for Blood Clots (SToPClot Trial)
Phase < 1
Waitlist Available
Led By Omar Saeed, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 8 and day 15
Awards & highlights
SToPClot Trial Summary
This trial will investigate whether a drug that improves nitric oxide signaling can reduce the increased platelet function that occurs when hemolysis is present.
Who is the study for?
This trial is for adults over 18 with severe heart failure who are using continuous flow (CF) pumps. Participants must be able to consent to the study and should not currently be taking sildenafil or nitrates, nor should they have an ongoing infection.Check my eligibility
What is being tested?
The study is testing whether sildenafil can reduce clotting problems caused by hemolysis in patients with CF pumps. It compares the effects of sildenafil against a placebo tablet that has no active ingredients.See study design
What are the potential side effects?
Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness, vision changes like blurring or blue-tinted sight, and in rare cases more serious cardiovascular events.
SToPClot Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 8 and day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 8 and day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in platelet activation and aggregation (aggregometry)
Secondary outcome measures
Change in pro-thrombotic inflammatory markers as measured by fibrinogen
Change in pro-thrombotic inflammatory markers as measured by hs CRP
Other outcome measures
Change in concentration of serum Endothelin-1
Change in serum Angiopoietin-2 to Angiopoietin-1 ratio
SToPClot Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: SildenafilActive Control1 Intervention
Baseline blood samples and study measurements will be acquired. Then 20 mg of the study drug will be administered. Then BP will be recorded every 30 minutes for two hours. If BP is stable (drop is < 5 mmHg after 2 hours and patient is asymptomatic), patient will proceed to take 20 mg of the study drug every 8 hours. The patient will return to clinic on day 8 and 20 mg of the study drug will be administered. After 2 hours blood samples and study measurements will be collected and the patient will resume 20 mg of the study for the next two doses. The patient will return for a third clinic visit on the next day and if BP is in the acceptable range, 40 mg of the study drug will be administered. If BP remains stable for 2 hours, then the patient will continue taking 40 mg every 8 hours. The patient will return to clinic on day 15 for a final study visit and will be given the last 40 mg dose of the study drug and after 2 hours blood samples and study measurements will be taken.
Group II: Placebo Oral TabletPlacebo Group1 Intervention
Negative control to understand the potential changes in platelet activation and aggregation in comparison to sildenafil.
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,176 Total Patients Enrolled
Omar Saeed, MDPrincipal Investigator - Montefiore Medical Center
Montefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Adults who use a durable CF pump at home.You are currently taking sildenafil or nitrates for medical reasons.You currently have an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Sildenafil
- Group 2: Placebo Oral Tablet
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor seeking participants at the moment?
"Clinicaltrials.gov has listed this trial as actively seeking participants; it was posted on June 3rd 2019 and amended November 3rd 2022."
Answered by AI
What is the current size of this research endeavor?
"That is correct. According to the clinicaltrials.gov database, this medical experiment was initially posted on June 3rd 2019 and has been recently rejuvenated on November 3rd 2022. The study requires 46 participants from a single site."
Answered by AI
To what conditions does Sildenafil typically offer a remedy?
"Sildenafil is an approved remedy for the treatment of premature ejaculation, NYHA functional class II-III pulmonary arterial hypertension, and other forms of pulmonary arterial hypertension."
Answered by AI
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