Status:
UNKNOWN
OPTImal Management of Antithrombotic Agents: OPTIMA-5
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Acute Coronary Syndrome (ACS)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients ...
Detailed Description
The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry method(LTA). Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint...
Eligibility Criteria
Inclusion
- ≥ 18 years.
- ACS patients.
- Patients who are treated with ticagrelor and do not tolerate it.
- Volunteer to participate and sign informed consent.
- Approved by national regulatory authorities ethics committees.
Exclusion
- Patients who are contraindicated, intolerant or resistant to clopidogrel.
- History of hematological disease or bleeding tendency; platelet count \< 100 × 10\^9 cells/L, or \> 600 × 10\^9 cells/L, hemoglobin \< 100 g/L.
- Abnormal liver or kidney function (ALT \> 3 ULN; estimated CrCl \< 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease.
- Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole.
- Malignancies or other comorbid conditions with life expectancy less than 1 year.
- Pregnant or lactating woman.
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04116931
Start Date
June 22 2020
End Date
June 30 2021
Last Update
August 25 2020
Active Locations (1)
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1
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029