ONSET and OFFSET of Ticagrelor in ESRD

NCT ID: NCT02163954

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-08-31

Brief Summary

Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.

Detailed Description

Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Recently, we demonstrated that patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. One of good option to overcome high platelet reactivity in ESRD patients would be ticagrelor which has been already shown improved clinical outcomes. But little is known the antiplatelet effects of ticagrelor in ESRD patients on HD. The present study was designed to determine the antiplatelet effect as well as the onset and offset action of ticagrelor compared with clopidogrel in patients with ESRD undergoing maintenance HD.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clopidogrel

Patients treated with clopidogrel for 14 days

Group Type: ACTIVE_COMPARATOR

Ticagrelor

Intervention Type: DRUG

After randomization, an initial loading dose of ticagrelor (180 mg) was given and maintenance doses (ticagrelor 90 mg twice daily) was treated for 14 days.

Clopidogrel

Intervention Type: DRUG

After randomization, an initial loading dose of clopidogrel (300 mg) was given and maintenance doses (clopidogrel 75 mg once daily) was treated for 14 days.

Ticagrelor

Patients treated with ticagrelor for 14 days

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

After randomization, an initial loading dose of ticagrelor (180 mg) was given and maintenance doses (ticagrelor 90 mg twice daily) was treated for 14 days.

Clopidogrel

Intervention Type: DRUG

After randomization, an initial loading dose of clopidogrel (300 mg) was given and maintenance doses (clopidogrel 75 mg once daily) was treated for 14 days.

Interventions

Ticagrelor

After randomization, an initial loading dose of ticagrelor (180 mg) was given and maintenance doses (ticagrelor 90 mg twice daily) was treated for 14 days.

Intervention Type: DRUG

Clopidogrel

After randomization, an initial loading dose of clopidogrel (300 mg) was given and maintenance doses (clopidogrel 75 mg once daily) was treated for 14 days.

Intervention Type: DRUG

Other Intervention Names

Ticagrelor (Brilinta); Clopidogrel (Plavix)

Eligibility Criteria

Inclusion Criteria

• ESRD patients undergoing regular (≥ 6 months) maintenance HD
• ongoing (≥ 2 months) treatment with clopidogrel
• P2Y12 reaction units (PRUs) were more than 235

Exclusion Criteria

• known allergies to aspirin, clopidogrel, or ticagrelor
• concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole)
• thrombocytopenia (platelet count <100,000/mm3)
• hematocrit <25%
• uncontrolled hyperglycemia (hemoglobin A1c >10%)
• liver disease (bilirubin level >2 mg/dl)
• symptomatic severe pulmonary disease
• active bleeding or bleeding diathesis
• gastrointestinal bleeding within the last 6 months
• hemodynamic instability
• acute coronary or cerebrovascular event within the last 3 months
• pregnancy
• any malignancy
• concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug
• recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyunghee University

OTHER

Sponsor Role: collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Weon Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital

Locations

Kyung Hee University Hospital

Seoul, , South Korea

Countries

South Korea

References

Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

Reference Type: DERIVED

PMID: 35224730 (View on PubMed)

Other Identifiers

Seoul, Korea

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PIANO3

Identifier Type: -

Identifier Source: org_study_id