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

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Clopidogrel first

Ticagrelor first

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Chronic kidney disease, End-Stage Renal Disease, eGFR, Ticagrelor, Clopidogrel

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Female and male, age between 20-75 years
Stage 3-5 chronic kidney disease (eGFR<60ml/min) patients or ESRD
Taking standard treatment dose of clopidogrel (75mg/day) for more than 1 week
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.
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).
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:

Oral anticoagulation therapy that cannot be stopped
Increased risk of bradycardia
Concomitant use of strong CYP3A inhibitor/inducers
Unwilling to sign inform consent
Allergic or contraindicated to any study medications

Sites / Locations

Department of Internal Medicine, National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Clopidogrel first

Ticagrelor first

Arm Description

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

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

Outcomes

Primary Outcome Measures

platelet VerifyNow inhibition rate and Platelet Residual Unit (PRU) values changes

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT02459288

First Posted

September 23, 2014

Last Updated

May 28, 2015

Sponsor

Ping-Yen Liu

1. Study Identification

Unique Protocol Identification Number

NCT02459288

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ping-Yen Liu

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Acute coronary syndrome, Chronic kidney disease, End-Stage Renal Disease, eGFR, Ticagrelor, Clopidogrel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel first

Arm Type

Experimental

Arm Description

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

Arm Title

Ticagrelor first

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Clopidogrel first

Other Intervention Name(s)

C-T

Intervention Description

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

Intervention Name(s)

Ticagrelor first

Other Intervention Name(s)

T-C

Intervention Description

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

Primary Outcome Measure Information:

Title

platelet VerifyNow inhibition rate and Platelet Residual Unit (PRU) values changes

Time Frame

baseline, 2 weeks and 4 weeks later (compare cross over effect)

Secondary Outcome Measure Information:

Title

Major bleeding events

Description

assessed by TIMI bleeding score: mild, moderate and severe; the transfusion of packed red blood cell amount; decreased count in Hb (>2.5)

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Myocardial infarction

Time Frame

1 year

Title

emergent condition with hospitalization need

Description

Number of subjects with an emergent condition that required hospitalization

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of informed consent prior to any study specific procedures Female and male, age between 20-75 years Stage 3-5 chronic kidney disease (eGFR<60ml/min) patients or ESRD Taking standard treatment dose of clopidogrel (75mg/day) for more than 1 week 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. 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). 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: Oral anticoagulation therapy that cannot be stopped Increased risk of bradycardia Concomitant use of strong CYP3A inhibitor/inducers Unwilling to sign inform consent Allergic or contraindicated to any study medications

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ping-Yen Liu, MD, PhD.

Phone

+88662353535

Ext

4602

larry@mail.ncku.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ping-Yen Liu, MD, PhD.

Organizational Affiliation

National Cheng Kung University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Internal Medicine, National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ping-Yen Liu, MD, PhD.

Phone

+88662353535

Ext

4602

larry@mail.ncku.edu.tw

12. IPD Sharing Statement

Citations:

PubMed Identifier

35224730

Citation

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.

Results Reference

derived

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

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