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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Ticagrelor

Study Locations (1)

California

  • University of Southern California - Los Angeles

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2014-02-16
Est. Completion 2016-11-30
Phase Phase 1

Sponsor

University of Southern California

617 total trials

What the Registry Record Tells You About NCT02091921

The ClinicalTrials.gov registry entry for NCT02091921 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (40% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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