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NCT02091921 · ClinicalTrials.gov registry record · Phase 1
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
A Phase 1 study of Critical Limb Ischemia, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT02091921: Completed Phase 1 study of Critical Limb Ischemia, sponsored by University of Southern California.
NCT02091921 is a Phase 1 study of Critical Limb Ischemia that has completed, run by University of Southern California. The registered enrollment target is 53 participants, below the 88-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02091921, a Phase 1 study of Critical Limb Ischemia, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a major cause of death and disability (secondary to myocardial infarction, stroke and amputation). The mortality in patients with CLI approaches 13-25% and 50% at one and five years respectively. High on-treatment platelet reactivity (HPR) in patients treated with aspirin and clopidogrel is associated with increased risk of recurrent cardiovascular events after percutaneous coronary interventions and coronary syndromes. Preliminary studies suggest that the prevalence of HPR in patients with critical limb ischemia treated with aspirin and clopidogrel is as high a 78.5%. In patients with coronary artery disease ticagrelor overcomes non-responsiveness to clopidogrel. However, the antiplatelet effect of ticagrelor in patients with critical limb ischemia is unknown.
Primary Outcome
Patients platelet inhibition was analyzed based on the P2Y12 reaction units (PRU) as high on treatment platelet reactivity (HPR), defined as P2Y12 reaction units (PRU) ≥208 and appropriate platelet inhibition on (API), defined as P2Y12 reaction units (PRU) \<208
Conditions Studied
Interventions
- DRUG Ticagrelor
Study Locations (1)
California
- University of Southern California - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2014-02-16 |
| Est. Completion | 2016-11-30 |
| Phase | Phase 1 |
What the finished NCT02091921 record still lists
NCT02091921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 88-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Critical Limb Ischemia appearing as the primary indexed condition, and to 1 intervention - of which Ticagrelor is the first listed.
NCT02091921 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02091921 about?
NCT02091921 is a clinical study titled "Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study". Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a major cause of death and disability (secondary to myocardial infarction, stroke and amputation). The mortality in pat...
What is the current status of trial NCT02091921?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2014-02-16. Estimated completion is 2016-11-30.
What conditions does trial NCT02091921 study?
This clinical trial studies the following conditions: Critical Limb Ischemia.
What interventions are being tested in trial NCT02091921?
The interventions under investigation include: Ticagrelor (DRUG).
Who is sponsoring clinical trial NCT02091921?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02091921 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02091921's enrollment target sits among peer trials
53 7th of 18 higher than 12 of 18 other Critical Limb Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Limb Ischemia 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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