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NCT02201394 · ClinicalTrials.gov registry record · Phase 4
Reversing Ticagrelor's Effects With Fresh Platelets
A Phase 4 study of Coronary Artery Disease, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02201394: Completed Phase 4 study of Coronary Artery Disease, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02201394 is a Phase 4 study of Coronary Artery Disease that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 20 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201394, a Phase 4 study of Coronary Artery Disease, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Acute coronary syndrome (ACS) patients treated with antiplatelet drugs who require coronary artery bypass grafting (CABG) surgery have to wait 5-7 days for the effects of the drugs to wean off. This treatment-devoid period leaves the patient vulnerable, therefore any means to shorten this period could be useful. The present study aims to investigate the possibility of reversing the antiplatelet effects of ticagrelor with the help of fresh donor platelets. Fresh platelets will be added to blood samples of treated patients in varying concentrations at specific timepoints to determine the time and amount of fresh platelets needed to normalize platelet reactivity in the treated samples.
Primary Outcome
Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.
Conditions Studied
Interventions
- DRUG Ticagrelor loading dose
- DRUG Aspirin loading dose
- DRUG Ticagrelor maintenance dose
- DRUG Aspirin maintenance dose
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
What the finished NCT02201394 record still lists
NCT02201394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 4 interventions - of which Ticagrelor loading dose is the first listed.
NCT02201394 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02201394 about?
NCT02201394 is a clinical study titled "Reversing Ticagrelor's Effects With Fresh Platelets". Acute coronary syndrome (ACS) patients treated with antiplatelet drugs who require coronary artery bypass grafting (CABG) surgery have to wait 5-7 days for the effects of the drugs to wean off. This treatment-devoid period leaves the patient vulnerable, therefore any means to shorten this period cou...
What is the current status of trial NCT02201394?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2014-07. Estimated completion is 2016-06.
What conditions does trial NCT02201394 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT02201394?
The interventions under investigation include: Ticagrelor loading dose (DRUG), Aspirin loading dose (DRUG), Ticagrelor maintenance dose (DRUG), Aspirin maintenance dose (DRUG).
Who is sponsoring clinical trial NCT02201394?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02201394 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02201394's enrollment target sits among peer trials
20 209th of 219 higher than 11 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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