The ACS Ethnicity Platelet Function Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medstar Research Institute
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01829659
First received: April 9, 2013
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This study is being done to assess the effects of the CTP inhibitor on the function of your platelets (cells within your blood that are involved in the formation of blood clots) and to assess whether you have responded to the ticagrelor well enough to prevent the formation of blood clots within the stent or site in which angioplasty was performed.

Recent studies have looked at how racial differences can affect platelet reactivity, the way blood clots. But these studies have not looked at the way different racial backgrounds can affect the way the blood forms clots. Minorities, such as African-Americans are underrepresented. Therefore, we are conducting this platelet reactivity study to better understand if there are differences in how this drug affects African-Americans from how they affect Caucasian patients undergoing percutaneous coronary intervention and receiving ticagrelor. These data will be compared to a historical control of Caucasian patients who underwent similar platelet function testing.


Condition Intervention
Acute Coronary Syndrome
Drug: Ticagrelor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ACS Ethnicity Platelet Function Study

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Ticagrelor Inhibition [ Time Frame: 1-2 days ] [ Designated as safety issue: No ]
    The primary objective of the study is to assess ticagrelor's inhibition of platelet activity using 3 assays simultaneously: VerifyNow P2Y12 (PRU), vasodilator-stimulated phosphoprotein phosphorylation (VASP) and light transmission aggregometry (LTA) in African-American patients presenting with ACS.


Secondary Outcome Measures:
  • Follow-up Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To evaluate the safety of ticagrelor treatment in African-American patients by assessment of adverse-events up to 30-day follow-up time point.


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AA Ticagrelor
African Americans who present with acute coronary syndrome (ACS) to the cath lab, and receive ticagrelor during their hospital stay.
Drug: Ticagrelor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Thirty African American patients with documented acute coronary syndrome who agree to participate in this clinical study and who sign an informed consent will be enrolled.

Race determination will be based on a patient's self-report, but patients enrolled in the trial must also report that all four of their grandparents were of the same race as theirs. Other races (Asian, Native American, etc) will be excluded from this study.

Criteria

Inclusion Criteria:

  • Female (post menopausal or surgically sterile) and/or male aged 18 years or older
  • Presenting with ACS fulfilling the following:

    1. Symptoms or new ECG changes (ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG)
    2. Elevation of biomarkers (CK-MB ≥2 ULN or troponin ≥ ULN)
  • Self-identified as African-American
  • Treatment with 75-100mg ASA daily

Exclusion Criteria:

  • Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, PE, DVT) for antithrombotic treatment during study period.
  • Fibrinolytic therapy within 48 hours before randomization
  • Concomitant therapy with a drug having possible interaction with ticagrelor. (concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer)
  • Increased bleeding risk including: recent (<30 days) GI bleeding, any history of intracranial, intraocular, retroperitoneal, or spinal bleeding, recent (<30 days of dosing) major trauma, sustained uncontrolled hypertension (systolic blood pressure [SBP]>180mmHg or diastolic blood pressure [DBP]>100mmHg), history of hemorrhagic disorders that can increase the risk of bleeding, platelet count less than 100,000 mm3 or hemoglobin <10 g/dL.
  • Any history of hemorrhagic stroke.
  • Contraindication or other reason that ASA or ticagrelor should not be administered (e.g., hypersensitivity, active bleeding, major surgery within 30 days of dosing).
  • Severe renal failure (creatinine clearance <30mL/min or patient requires dialysis)
  • History of moderate or severe hepatic impairment with aspartate amino transferace, alanine amino transferase or total bilirubin > 1.5 x upper limit of the reference range.
  • Pregnant or lactating women.
  • Patients receiving any glycoprotein IIb/IIIa inhibitors <8 hours before platelet reactivity testing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829659

Contacts
Contact: Ron Waksman, MD 202-877-5975

Locations
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ron Waksman, MD    202-877-5975      
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01829659     History of Changes
Other Study ID Numbers: ACS Brilinta AZ
Study First Received: April 9, 2013
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014