Study Comparing Treatment Effectiveness of Guideline Indicated APT for ACS in Patients With CKD

NCT03150667 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 16-041
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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).

Conditions

Chronic Kidney Diseases; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Occurrence of bleeding

  1 year from date of admission

• Need for ischemia driven urgent coronary revascularization

  1 year from date of admission

• Occurrence of MACE events

  1 year from date of admission

• Length of hospital stay and readmission

  1 year from date of admission

Study Arms (2)

Ticagrelor Arm

ACTIVE COMPARATOR

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

Clopidogrel

ACTIVE COMPARATOR

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

Interventions

Ticagrelor DRUG

Ticagrelor in patients with CKD presenting with ACS.

Also known as: Brilinta

Ticagrelor Arm

Clopidogrel DRUG

Clopidogrel in patients with CKD presenting with ACS.

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (2)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

VA North Texas Health Care System

Dallas, Texas, 75216, United States

RECRUITING

Related Publications (10)

• 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. doi: 10.1016/s0735-1097(02)01745-x.

  PMID: 11923033 BACKGROUND

• 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.

  PMID: 18371477 BACKGROUND

• 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.

  PMID: 18721508 BACKGROUND

• 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. doi: 10.1038/sj.ki.5001934. Epub 2006 Oct 18.

  PMID: 17051142 BACKGROUND

• 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.

  PMID: 19427428 BACKGROUND

• 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.

  PMID: 20065168 BACKGROUND

• 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.

  PMID: 18450830 BACKGROUND

• 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. doi: 10.1001/jama.293.17.2126.

  PMID: 15870416 BACKGROUND

• 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.

  PMID: 24662983 BACKGROUND

• 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.

  PMID: 35224730 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Coronary Syndrome

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Subhash Banerjee, MD

CONTACT

214-867-1608; subhash.banerjee@utsouthwestern.edu

Amutharani Baskar, MBBS

CONTACT

214-857-0305; amutharani.baskar@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Cardiology

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 12, 2017
• Study Start: April 10, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2020
• Last Updated: May 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)