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NCT01743937 · ClinicalTrials.gov registry record · Phase 4
A Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT01743937 is a Phase 4 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 18 participants.
The verdict
NCT01743937, a Phase 4 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study Summary
Antiplatelet therapy remains a cornerstone in the treatment of acute and chronic coronary artery disease. Aspirin was the first such therapy to prove its benefits in acute myocardial infarction. Compared to aspirin monotherapy, the combination of aspirin and clopidogrel, a thienopyridine P2Y12 inhibitor, has been demonstrated to reduce adverse event rates among patients with acute coronary syndromes (with or without ST-segment elevation) and those receiving intracoronary stents. In the Triton-TIMI 38 trial a novel thienopyridine, prasugrel, was compared to clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Although prasugrel significantly reduced recurrent myocardial infarction, bleeding rates were increased and no improvement in cardiac or all-cause mortality was demonstrated. However, in 2009, the authors of the PLATO trial demonstrated an unexpected cardiovascular mortality benefit with ticagrelor over clopidogrel, an endpoint not previously met by any other antiplatelet agent against an active comparator. Based on the reproducible adverse events seen in the DISPERSE, DISPERSE-2, and PLATO trials, an adenosine-mediated effect of ticagrelor is proposed. Hypothesis: The aim of this study is to test the hypothesis that ticagrelor produces pharmacologic ischemic preconditioning, an undescribed potential off-label property of ticagrelor that could represent a plausible mechanism for its effects on cardiovascular mortality.
Interventions
- PROCEDURE Coronary occlusion with balloon inflation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01743937
The ClinicalTrials.gov registry entry for NCT01743937 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Coronary occlusion with balloon inflation is the first listed.
NCT01743937 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01743937 about?
NCT01743937 is a clinical study titled "A Trial Comparing the Ischemic Preconditioning Effects of Ticagrelor and Clopidogrel in Humans". Antiplatelet therapy remains a cornerstone in the treatment of acute and chronic coronary artery disease. Aspirin was the first such therapy to prove its benefits in acute myocardial infarction. Compared to aspirin monotherapy, the combination of aspirin and clopidogrel, a thienopyridine P2Y12 inhib...
What is the current status of trial NCT01743937?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2013-01. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01743937?
The interventions under investigation include: Coronary occlusion with balloon inflation (PROCEDURE).
Who is sponsoring clinical trial NCT01743937?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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