Status:
COMPLETED
The ACS Ethnicity Platelet Function Study
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Female (post menopausal or surgically sterile) and/or male aged 18 years or older
- Presenting with ACS fulfilling the following:
- Symptoms or new ECG changes (ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG)
- Elevation of biomarkers (CK-MB ≥2 ULN or troponin ≥ ULN)
- Self-identified as African-American
- Treatment with 75-100mg ASA daily
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01829659
Start Date
May 1 2013
End Date
May 1 2016
Last Update
June 8 2018
Active Locations (1)
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1
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010