Acute Coronary Syndrome Clinical Trial
— CPRS-CKDOfficial title:
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).
Status | Recruiting |
Enrollment | 220 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | VA North Texas Health Care System | Dallas | Texas |
United States | Durham VA Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
North Texas Veterans Healthcare System |
United States,
Best PJ, Lennon R, Ting HH, Bell MR, Rihal CS, Holmes DR, Berger PB. The impact of renal insufficiency on clinical outcomes in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol. 2002 Apr 3;39(7):1113-9. — View Citation
Best PJ, Steinhubl SR, Berger PB, Dasgupta A, Brennan DM, Szczech LA, Califf RM, Topol EJ; CREDO Investigators. The efficacy and safety of short- and long-term dual antiplatelet therapy in patients with mild or moderate chronic kidney disease: results from the Clopidogrel for the Reduction of Events During Observation (CREDO) trial. Am Heart J. 2008 Apr;155(4):687-93. doi: 10.1016/j.ahj.2007.10.046. Epub 2008 Feb 21. — View Citation
Bonello L, De Labriolle A, Roy P, Steinberg DH, Okabe T, Pinto Slottow TL, Xue Z, Torguson R, Suddath WO, Satler LF, Kent KM, Pichard AD, Lindsay J, Waksman R. Impact of optimal medical therapy and revascularization on outcome of patients with chronic kidney disease and on dialysis who presented with acute coronary syndrome. Am J Cardiol. 2008 Sep 1;102(5):535-40. doi: 10.1016/j.amjcard.2008.04.040. Epub 2008 Jun 26. — View Citation
Charytan D, Kuntz RE. The exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease. Kidney Int. 2006 Dec;70(11):2021-30. Epub 2006 Oct 18. — View Citation
Dasgupta A, Steinhubl SR, Bhatt DL, Berger PB, Shao M, Mak KH, Fox KA, Montalescot G, Weber MA, Haffner SM, Dimas AP, Steg PG, Topol EJ; CHARISMA Investigators. Clinical outcomes of patients with diabetic nephropathy randomized to clopidogrel plus aspirin versus aspirin alone (a post hoc analysis of the clopidogrel for high atherothrombotic risk and ischemic stabilization, management, and avoidance [CHARISMA] trial). Am J Cardiol. 2009 May 15;103(10):1359-63. doi: 10.1016/j.amjcard.2009.01.342. Epub 2009 Apr 1. — View Citation
Fox CS, Muntner P, Chen AY, Alexander KP, Roe MT, Cannon CP, Saucedo JF, Kontos MC, Wiviott SD; Acute Coronary Treatment and Intervention Outcomes Network registry. Use of evidence-based therapies in short-term outcomes of ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction in patients with chronic kidney disease: a report from the National Cardiovascular Data Acute Coronary Treatment and Intervention Outcomes Network registry. Circulation. 2010 Jan 26;121(3):357-65. doi: 10.1161/CIRCULATIONAHA.109.865352. Epub 2010 Jan 11. — View Citation
Hwang SJ, Lin MY, Chen HC, Hwang SC, Yang WC, Hsu CC, Chiu HC, Mau LW. Increased risk of mortality in the elderly population with late-stage chronic kidney disease: a cohort study in Taiwan. Nephrol Dial Transplant. 2008 Oct;23(10):3192-8. doi: 10.1093/ndt/gfn222. Epub 2008 May 1. — View Citation
Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30. — View Citation
James MT, Pannu N. Early-invasive strategies for the management of coronary heart disease in chronic kidney disease: is acute kidney injury a consideration? Curr Opin Nephrol Hypertens. 2014 May;23(3):283-90. doi: 10.1097/01.mnh.0000444819.03121.4b. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of all-cause mortality, non-fatal myocardial infarction (MI), or ischemic stroke | Occurrence of all-cause mortality, non-fatal myocardial infarction (MI), or ischemic stroke | 1 year from date of admission | |
Secondary | Occurrence of bleeding | Incidence of BARC >3 bleeding over a period of 1-year from hospital admission | 1 year from date of admission | |
Secondary | Need for ischemia driven urgent coronary revascularization | Need for ischemia driven urgent coronary revascularization (UCR) over a period of 1-year from hospital admission | 1 year from date of admission | |
Secondary | Occurrence of MACE events | 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 | |
Secondary | Length of hospital stay and readmission | Post-PCI length of hospital stay and readmission = 1 year of initial discharge | 1 year from date of admission |
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