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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases Acute Coronary Syndrome||Drug: Ticagrelor Drug: Clopidogrel||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
Clopidogrel in patients with CKD presenting with ACS.
Other Name: Plavix
- 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
- 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
- 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
- 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
- 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
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
|Contact: Subhash Banerjee, MDfirstname.lastname@example.org|
|Contact: Amutharani Baskar, MBBSemail@example.com|
|United States, North Carolina|
|Durham VA Medical Center||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Sunil Rao, MD 919-286-0411 firstname.lastname@example.org|
|Contact: Marc Samsky, MD email@example.com|
|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 firstname.lastname@example.org|
|Contact: Amutharani Baskar, MBBS 214-857-0305 email@example.com|