Study Comparing Treatment Effectiveness of Guideline Indicated APT for ACS in Patients With CKD (CPRS-CKD)

May 24, 2018 updated by: Subhash Banerjee, North Texas Veterans Healthcare System

Pragmatic Randomized Controlled Trial Comparing Treatment Effectiveness of Guideline Indicated Anti-platelet Therapy for Acute Coronary Syndrome in Patients With Chronic Kidney Disease

To compare clinical outcomes in patients with chronic kidney disease (CKD) presenting with an acute coronary syndrome (ACS) treated with clopidogrel or ticagrelor (both FDA approved and guideline indicated drugs for treating these patients upstream managed medically or with coronary revascularization).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this trial is to see if ticagrelor is a better antiplatelet treatment option than clopidogrel for dual antiplatelet therapy (with aspirin) in chronic kidney disease (CKD) patients presenting with acute coronary syndrome (ACS). This study will be a comparative effectiveness trial of the two guideline-based treatments for patients with ACS with CKD, who are at a significantly higher risk of mortality and morbidity and often receive sub-optimal treatment. Ticagrelor and clopidogrel are the only two drugs in ACS that are approved for upstream (on admission) use both in CKD and non-CKD patients who are managed both medically (conservatively) or with coronary revascularization (with PCI-percutaneous coronary revascularization or CABG-coronary artery bypass graft surgery). Both of these drugs are not cleared renally and do not require dose adjustments in any stage of CKD.

Moreover, as a significant majority of CKD patients presenting with ACS are initially cared for by internists, hospitalists, and nephrologists, execution of this study at VA hospitals will strengthen collaboration between these specialties with cardiology and help adopt best practice pathways across multiple services participating in the care of this high-risk patient population. Finally, the study and its findings will for the first time provide randomized clinical trial evidence to guide the care of CKD patients with ACS who are at a high risk for both recurrent ischemia and bleeding complications.

Hypothesis to be tested: The Investigators hypothesize that use of guideline-indicated dual antiplatelet therapy (DAPT) with ticagrelor compared to clopidogrel in CKD patients presenting with ACS will reduce ischemic cardiovascular events at 1 year, additionally without a significant increase in severe bleeding (Bleeding Associated Research Consortium or BARC >3 category) over the same period. This hypothesis is based on prior subgroup analysis of published studies.

Randomized patients will be followed for 1 year from date of admission and events recorded through chart review. For patients who are event free, a phone follow-up will be done at the end of 1 year to note events, which will be recorded on the medical chart as well.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospital admission with non-emergent ACS qualifying diagnosis: chest pain, unstable angina or NSTEMI
  • A decision to prescribe clopidogrel or ticagrelor in addition to aspirin (DAPT-dual antiplatelet therapy) by the attending physician
  • A eGFR< 60 mL/min per 1.73 m.2 (as defined in the EMR or CPRS reported results)

Exclusion Criteria:

  • Diagnosis of ST Elevation Myocardial Infarction (STEMI) at admission
  • History of intra-cranial hemorrhage
  • Bleeding requiring hospitalization, surgery, or transfusion within the past 3 months
  • Life expectancy in the opinion of the provider < 6 months
  • Chronic antithrombotic therapy
  • Known allergy to clopidogrel or ticagrelor
  • Patients on hemodialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ticagrelor Arm
Eligible patients randomized to the Ticagrelor arm will receive open label drug at a dose selected by their providers along with 81mg aspirin. These patients will be followed for 1 year through chart review for events. For event free patients, a phone follow-up will be done at the end of 1 year to record events These events be documented in the medical records.
Drug: Ticagrelor
Ticagrelor in patients with CKD presenting with ACS.
Other Names:
  • Brilinta
Active Comparator: Clopidogrel
Eligible patients randomized to the Clopidogrel arm will receive open label drug at a dose selected by their providers along with 81mg aspirin. These patients will be followed for 1 year through chart review for events. For event free patients, a phone follow-up will be done at the end of 1 year to record events These events be documented in the medical records
Drug: Clopidogrel
Clopidogrel in patients with CKD presenting with ACS.
Other Names:
  • Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of all-cause mortality, non-fatal myocardial infarction (MI), or ischemic stroke
Time Frame: 1 year from date of admission
Occurrence of all-cause mortality, non-fatal myocardial infarction (MI), or ischemic stroke
1 year from date of admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of bleeding
Time Frame: 1 year from date of admission
Incidence of BARC >3 bleeding over a period of 1-year from hospital admission
1 year from date of admission
Need for ischemia driven urgent coronary revascularization
Time Frame: 1 year from date of admission
Need for ischemia driven urgent coronary revascularization (UCR) over a period of 1-year from hospital admission
1 year from date of admission
Occurrence of MACE events
Time Frame: 1 year from date of admission
Comparison of 12-month post-randomization MACE events, a composite of all-cause death, MI, ischemic stroke, or UCR in participant groups
1 year from date of admission
Length of hospital stay and readmission
Time Frame: 1 year from date of admission
Post-PCI length of hospital stay and readmission ≤ 1 year of initial discharge
1 year from date of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2017

Primary Completion (Anticipated)

April 30, 2019

Study Completion (Anticipated)

April 30, 2020

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Ticagrelor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe