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

Acute Coronary Syndrome Clinical Trial

— APROVE-CKD  

Official title:

A comParison on Platelet Resistance With Ticagrelor or Standard-Dose Clopidogrel Study Among SeVerE Chronic Kidney Disease/ End-Stage-Renal-Disease Patients With Recent Acute Coronary Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02459288
• Other study ID #: A-BR-102-085
• Status: Recruiting
• Phase: Phase 4
• First received: September 23, 2014
• Last updated: May 28, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: National Cheng-Kung University Hospital
• Contact: Ping-Yen Liu, MD, PhD.
• Phone: +88662353535
• Email: larry[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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).

7. For patients who had an acute coronary syndrome with ST-segment elevation, the following two inclusion criteria had to be met: persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chronic Kidney Disease
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Taiwan	Department of Internal Medicine, National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Ping-Yen Liu

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Myocardial infarction		1 year	Yes
Other	emergent condition with hospitalization need	Number of subjects with an emergent condition that required hospitalization	30 days	Yes
Primary	platelet VerifyNow inhibition rate and Platelet Residual Unit (PRU) values changes		baseline, 2 weeks and 4 weeks later (compare cross over effect)	No
Secondary	Major bleeding events	assessed by TIMI bleeding score: mild, moderate and severe; the transfusion of packed red blood cell amount; decreased count in Hb (>2.5)	1 year	Yes