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NCT03774394
Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus
Phase 4 trial testing Clopidogrel in Chronic Kidney Disease (CKD) in 61 participants. Completed in 31 May 2022.
23 May 2022
Quick facts
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 22 August 2019 |
| Primary completion | 23 May 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Clopidogrel (clopidogrel) — full drug profile →
- Clopidogrel active metabolite — full drug profile →
Conditions studied
- Chronic Kidney Disease (CKD) — all drugs for Chronic Kidney Disease (CKD) →
- Type 2 Diabetes Mellitus (T2DM) — all drugs for Type 2 Diabetes Mellitus (T2DM) →
- Coronary Artery Disease (CAD) — all drugs for Coronary Artery Disease (CAD) →
Sponsor
University of Florida
Who can join
18 and older, any sex, with Chronic Kidney Disease (CKD) or Type 2 Diabetes Mellitus (T2DM). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with diabetes mellitus (DM) and chronic kidney disease (CKD) are at increased risk of atherothrombotic events. Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor in patients with coronary artery disease (CAD). However, despite its benefits, many patients still experience recurrent atherothrombotic events. The proposed study will test the central hypothesis that in DM patients the presence of CKD reduces clopidogrel-mediated P2Y12 inhibitory effects through synergistic mechanisms, which include upregulation of the P2Y12 signaling pathway and impaired clopidogrel metabolism.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The developmental journey of therapies targeting purine receptors: from basic science to clinical trials.
Han S, Suzuki-Kerr H, Vlajkovic SM, Thorne PR. · · 2022 · cited 9× · PMID 36173587 · DOI 10.1007/s11302-022-09896-w -
Clopidogrel-Mediated P2Y<sub>12</sub> Inhibition According to Renal Function in Patients With Diabetes Mellitus and CAD.
Ortega-Paz L, Franchi F, Rollini F, Galli M, et al · · 2024 · cited 4× · PMID 39170956 · DOI 10.1016/j.jacbts.2024.03.003
Verify or expand the search:
- PubMed search for NCT03774394
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07040787 — Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects · Phase 1 · completed
Other recruiting trials for Chronic Kidney Disease (CKD)
Currently open trials in the same condition.
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Other University of Florida trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03774394 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florida
- Last refreshed: 21 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03774394.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing