Recruiting

APT

Sponsor:

North Texas Veterans Healthcare System

Code:

NCT03150667

Conditions

Chronic Kidney Diseases

Acute Coronary Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ticagrelor

Clopidogrel

Study Details

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

Study ID

NCT03150667

Start date

Apr 10, 2017

Status verified date

May, 2018

Completion date

Apr 30, 2020

Anticipated

Primary completion date

Apr 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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

Interventions

Ticagrelor

Ticagrelor in patients with CKD presenting with ACS.

Clopidogrel

Clopidogrel in patients with CKD presenting with ACS.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Subhash Banerjee, MD

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

Amutharani Baskar, MBBS

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

Locations

Durham VA Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Sunil Rao, MD

919-286-0411sunil.rao@va.gov

Marc Samsky, MD

marc.samsky@dule.edu

Principal Investigator:

Sunil Rao, MD

VA North Texas Health Care System

Recruiting

Dallas, Texas, United States, 75216

Contacts

Subhash Banerjee, MD

214-857-1608subhash.banerjee@utsouthwestern.edu

Amutharani Baskar, MBBS

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

More Information

Sponsor

North Texas Veterans Healthcare System

Last update posted

May 25, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by North Texas Veterans Healthcare System on 2018-05-25.