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NCT01768637 · ClinicalTrials.gov registry record · Phase 1
Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin Study
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01768637 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 48 participants.
The verdict
NCT01768637, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
Higher coronary in-stent thromboses and bleeding complications on anti-platelet agents are more common in Chronic Kidney Disease vs. non-Chronic Kidney Disease patients. Poor inhibition of platelet aggregation by anti-platelet agents predicts future cardiovascular events. Clinical practice guidelines are ambiguous about the use of these agents in Chronic Kidney Disease due to lack of controlled studies. The investigators hypothesize that patients with Chronic Kidney Disease compared with non-Chronic Kidney Disease have reduced platelet aggregation and poor platelet inhibitory response to aspirin. The aims are to 1) define the range of whole blood platelet aggregation in stages 3-5 Chronic Kidney Disease patients; 2) investigate whether patients with stages 4-5 Chronic Kidney Disease vs. non-Chronic Kidney Disease have lower platelet aggregation or impaired von Willebrand Factor activity; and 3) compare inhibition of platelet aggregation from baseline after 2 weeks of aspirin therapy and another 2 weeks of clopidogrel therapy added to aspirin in Chronic Kidney Disease vs. non-Chronic Kidney Disease patients. Accomplishing these aims will provide pilot data to power future studies of targeted anti-platelet agent treatments in Chronic Kidney Disease in order to improve cardiovascular outcomes.
Interventions
- DRUG Aspirin
- DRUG Clopidogrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01768637
The ClinicalTrials.gov registry entry for NCT01768637 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 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 2 interventions - of which Aspirin is the first listed.
NCT01768637 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01768637 about?
NCT01768637 is a clinical study titled "Whole Blood Platelet Aggregation in Chronic Kidney Disease Patients on Aspirin Study". Higher coronary in-stent thromboses and bleeding complications on anti-platelet agents are more common in Chronic Kidney Disease vs. non-Chronic Kidney Disease patients. Poor inhibition of platelet aggregation by anti-platelet agents predicts future cardiovascular events. Clinical practice guideline...
What is the current status of trial NCT01768637?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01768637?
The interventions under investigation include: Aspirin (DRUG), Clopidogrel (DRUG).
Who is sponsoring clinical trial NCT01768637?
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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