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

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ClinicalTrials.gov Identifier: NCT03150667
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Subhash Banerjee, North Texas Veterans Healthcare System

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Acute Coronary Syndrome Drug: Ticagrelor Drug: Clopidogrel Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pragmatic Randomized Controlled Trial Comparing Treatment Effectiveness of Guideline Indicated Anti-platelet Therapy for Acute Coronary Syndrome in Patients With Chronic Kidney Disease
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: 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 Name: Plavix




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150667


Contacts
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Contact: Subhash Banerjee, MD 214-867-1608 subhash.banerjee@utsouthwestern.edu
Contact: Amutharani Baskar, MBBS 214-857-0305 amutharani.baskar@va.gov

Locations
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United States, North Carolina
Durham VA Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Sunil Rao, MD    919-286-0411    sunil.rao@va.gov   
Contact: Marc Samsky, MD       marc.samsky@dule.edu   
Principal Investigator: Sunil Rao, MD         
United States, Texas
VA North Texas Health Care System Recruiting
Dallas, Texas, United States, 75216
Contact: Subhash Banerjee, MD    214-857-1608    subhash.banerjee@utsouthwestern.edu   
Contact: Amutharani Baskar, MBBS    214-857-0305    amutharani.baskar@va.gov   
Sponsors and Collaborators
North Texas Veterans Healthcare System

Publications:

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Responsible Party: Subhash Banerjee, Chief, Division of Cardiology, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT03150667     History of Changes
Other Study ID Numbers: 16-041
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Kidney Diseases
Renal Insufficiency, Chronic
Acute Coronary Syndrome
Disease
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs