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Platelet P2Y12 Receptor Inhibitor

Clopidogrel for Chronic Kidney Disease

Phase 4
Waitlist Available
Led By Francesco Franchi, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Angiographically documented CAD
Type 2 DM, defined according to ADA definition, on treatment with oral hypoglycemic agents and/or insulin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Study Summary

This trial will test if a commonly used heart medication is less effective in patients with diabetes who also have kidney disease.

Eligible Conditions
  • Chronic Kidney Disease
  • Type 2 Diabetes
  • Coronary Heart Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Clopidogrel Active Metabolite Concentration
Other outcome measures
P2Y12 Reaction Units (PRU) Assessed by VerifyNow. The Cutoff for High Platelet Reactivity is >208.
Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diabetes Mellitus patients with Chronic Kidney DiseaseExperimental Treatment2 Interventions
Patients with CKD will be administered a 600-mg LD of Clopidogrel followed by a single 75-mg MD administered after 24 hours. Blood samples collected at baseline will be incubated with clopidogrel active metabolite.
Group II: Diabetes Mellitus patients without Chronic Kidney DiseaseActive Control2 Interventions
Patients without CKD will be administered a 600-mg LD of Clopidogrel followed by a single 75-mg MD administered after 24 hours. Blood samples collected at baseline will be incubated with clopidogrel active metabolite.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clopidogrel active metabolite
2019
Completed Phase 4
~70
Clopidogrel
2010
Completed Phase 4
~9160

Find a Location

Who is running the clinical trial?

Scott R. MacKenzie FoundationOTHER
4 Previous Clinical Trials
445 Total Patients Enrolled
University of FloridaLead Sponsor
1,338 Previous Clinical Trials
715,794 Total Patients Enrolled
Francesco Franchi, MDPrincipal InvestigatorUniversity of Florida
5 Previous Clinical Trials
967 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus
2019. "Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03774394.
~11 spots leftby Apr 2025
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