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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clopidogrel-600 mg-12h | Experimental | clopidogrel 600 mg loading dose (LD) 12 hours after the last maintenance dose(MD) of ticagrelor followed by 75 mg MD daily |
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| clopidogrel-600 mg-24h | Experimental | clopidogrel 600 mg loading dose (LD) 24 hours after the last maintenance dose(MD) of ticagrelor followed by 75 mg MD daily |
|
| clopidogrel-75 mg-12h | Experimental | clopidogrel 75 mg maintenance dose(MD) 12 hours after the last MD of ticagrelor |
|
| clopidogrel-75 mg-24h | Experimental | clopidogrel 75 mg maintenance dose(MD) 24 hours after the last MD of ticagrelor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switch ticagrelor to clopidogrel | Drug | Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose(MD)12/24 hours after the last MD of ticagrelor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of platelet aggregation between different time points | Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA). | baseline,4 hours,8 hours,24 hours,48 hours,72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical endpoint event | 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunjian Li, Dr, PhD | Contact | +86-13701465229 | drcjli@hotmail.com | |
| Qian Gu | Contact | +86-18351972592 | Solsticeg@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunjian Li, Dr, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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