Phase 3
Completed N=76
Chronic Kidney Disease (CKD) Platelet Study
Chronic Kidney Diseases · Heart Failure · Stroke, Ischemic
Source: ClinicalTrials.gov NCT03649711 ↗
Enrolled (actual)
76
Serious AEs
1.4%
Results posted
Dec 2022
Primary outcomePrimary: ADP Induced Platelet Aggregation — 0; 6; 1 ohms — p=0.002
◆ Published Evidence
Established
41citations · ~10 / year
Antiplatelet agents for chronic kidney disease.
Summary
This study evaluates how aspirin, clopidogrel and ticagrelor work in people with chronic kidney disease (CKD) compared to people with normal kidneys. In the first part of the study, half of CKD participants will be randomly assigned to ticagrelor and aspirin, while the other half will be assigned to clopidogrel and aspirin in a blinded fashion. The treatment duration will be two weeks. After recruiting CKD participants the investigator will recruit controls with normal kidney function that will receive only ticagrelor and aspirin for two weeks.
Linked Publications (2)
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Antiplatelet agents for chronic kidney disease.
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Ticagrelor inhibits platelet aggregation and reduces inflammatory burden more than clopidogrel in patients with stages 4 or 5 chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADP Induced Platelet Aggregation |
0; 6; 1 | 0.002 sig |
| SECONDARY Platelet Surface P-selectin Expression |
1002.5; 1037.5; 1052 | 0.22 |
Eligibility Criteria
Inclusion Criteria
- Males and females, aged 18-91 years
- Ability to understand and sign informed consent after the nature of the study has been fully explained
- CKD participants: Non-dialysis CKD patients: Presence of CKD with an estimated GFR of 90 mL/min/1.73 m2 as determined by the CKD-EPI creatinine-based formula and a urine albumin-to-creatinine ratio 20,000/μL, or platelet count <50,000/μL
- Any active malignancy or liver disease.
- Pregnancy
- Positive urine pregnancy test in a woman of childbearing potential prior to study entry. A female of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Patients must not be nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Data sourced from ClinicalTrials.gov (NCT03649711) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.