Clinical trial NCT04116931: OPTImal Management of Antithrombotic Agents: OPTIMA-5
Official title: A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome (ACS)
Keywords: Dual antiplatelet therapy (DAPT)
Platelet function
Clopidogrel
Ticagrelor
Switch
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.

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 (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.

Eligibility criteria: Inclusion Criteria:

* ≥ 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 Criteria:

* 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.

Primary outcomes:
measure: Change of platelet aggregation between different time points
timeFrame: baseline,4 hours,8 hours,24 hours,48 hours,72 hours
Secondary outcomes:
measure: Rate of clinical endpoint event
timeFrame: 30 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Principal Investigator
name: Chunjian Li, Dr, PhD
role: PRINCIPAL_INVESTIGATOR
References: