Platelet Resistance With Ticagrelor or Standard-Dose Clopidogrel Among CKD and ACS Patients

NCT ID: NCT02459288

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief Summary

A 4 week-duration cross-over study on Ticagrelor and Clopidogrel for the Acute Coronary Syndrome (ACS) and Chronic Kidney Disease (CKD) subjects, focusing on the platelet inhibition and safety observation.

Detailed Description

Acute coronary syndrome is a high mortality and costly disease. Antiplatelet therapies, including aspirin and P2Y12 antagonist, play important roles at the acute and subacute stage treatment for acute coronary syndrome, especially after coronary stent implantation. Patients with decreased estimated glomerular filtration rate (eGFR) experience higher cardiovascular morbidity and mortality. Clopidogrel, one of P2Y12 receptor antagonists, inhibits the receptor's activation by blocking its interaction with ADP. However, the efficacy of clopidogrel shows substantial variation and residual platelet reactivity, which is related to adverse cardiovascular outcome, especially in impaired renal function. Our study aims to check the platelet inhibition rate comparing both medication with a cross-over study among CKD subjects and ACS condition.

Conditions

Acute Coronary Syndrome; Chronic Kidney Disease; End-Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clopidogrel first

Clopidogrel (Plavix) 75 mg qd, 2 weeks; followed with Ticagrelor (Brilinta) 90 mg bd, 2 weeks

Group Type: EXPERIMENTAL

Clopidogrel first

Intervention Type: DRUG

After randomization, 2 weeks Clopidogrel (Plavix) 75 mg QD will be given and then crossover with following 2 weeks Ticagrelor (Brilinta) 90 mg bd

Ticagrelor first

Ticagrelor (Brilinta) 90 mg bd, 2 weeks; followed with Clopidogrel (Plavix) 75 mg qd, 2 weeks

Group Type: EXPERIMENTAL

Ticagrelor first

Intervention Type: DRUG

After randomization, 2 weeks Ticagrelor (Brilinta) 90 mg bd will be given then crossover with following 2 weeks Clopidogrel (Plavix) 75 mg QD

Interventions

Clopidogrel first

After randomization, 2 weeks Clopidogrel (Plavix) 75 mg QD will be given and then crossover with following 2 weeks Ticagrelor (Brilinta) 90 mg bd

Intervention Type: DRUG

Ticagrelor first

After randomization, 2 weeks Ticagrelor (Brilinta) 90 mg bd will be given then crossover with following 2 weeks Clopidogrel (Plavix) 75 mg QD

Intervention Type: DRUG

Other Intervention Names

C-T; T-C

Eligibility Criteria

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures

2. Female and male, age between 20-75 years

3. Stage 3-5 chronic kidney disease (eGFR<60ml/min) patients or ESRD

4. Taking standard treatment dose of clopidogrel (75mg/day) for more than 1 week

5. Patients were eligible for enrollment if they were hospitalized for an acute coronary syndrome, with or without ST-segment elevation, with an onset of symptoms during the past 6 months.

6. For patients who had an acute coronary syndrome without ST-segment elevation, at least two of the following three criteria had to be met: ST-segment changes on electrocardiography, indicating ischemia; a positive test of a biomarker, indicating myocardial necrosis; or one of several risk factors (age ≥60 years; previous myocardial infarction or coronary-artery bypass grafting [CABG]; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease).

Exclusion Criteria

1. Oral anticoagulation therapy that cannot be stopped

2. Increased risk of bradycardia

3. Concomitant use of strong CYP3A inhibitor/inducers

4. Unwilling to sign inform consent

5. Allergic or contraindicated to any study medications

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ping-Yen Liu

OTHER

Sponsor Role: lead

Responsible Party

Ping-Yen Liu

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ping-Yen Liu, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

Department of Internal Medicine, National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ping-Yen Liu, MD, PhD.

Role: CONTACT

larry@mail.ncku.edu.tw

+88662353535 ext. 4602

Facility Contacts

Ping-Yen Liu, MD, PhD.

Role: primary

larry@mail.ncku.edu.tw

+88662353535 ext. 4602

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

A-BR-102-085

Identifier Type: -

Identifier Source: org_study_id