Coronary Artery Disease
Conditions
Brief summary
To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.
Detailed description
This is a multi-center, randomized, single-blind, investigator-initiated study with a parallel design. Patients with coronary artery disease undergoing percutaneous coronary intervention and presenting high platelet reactivity on clopidogrel as assessed with the PL-11 analyzer (platelet maximum aggregation ratio \[MAR%\] ≥ 55 %) at 2 hours post-clopidogrel 300mg LD (Day 0), will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Ticagrelor 180 mg immediate loading (on Day 0) followed by 180mg/day starting from Day 1 until Day 365 (12 months after randomization). Group Β: Clopidogrel 150mg per day, starting from Day 1 until Day 365 (12 months after randomization). Platelet reactivity assessment will be performed before randomization (Day 0), and 3-day after randomization (Day 3). Documentation of major adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events) will be performed until 12 months.
Interventions
DRUGTicagrelor
Daily administration of ticagrelor 180mg for 12 months
DRUGClopidogrel
Daily administration of clopidogrel 150mg for 12 months
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who agreed to the experimental plan which was permitted by IRB; * Patients planned to take dual antiplatelet therapy for 12 months.
Exclusion criteria
* Severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit; * Renal dysfunction defined as eGFR \< 30ml/min/1.73m\^2; * Co-morbidity with an estimated life expectancy of \< 50 % at 12 months; * Scheduled surgery in the next 12 months, which resulted protocol changes; * Known allergy against study drug or device; * Use of glycoprotein IIb/IIIa inhibitor during the perioperative period; * Anticoagulation treatment including warfarin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-Month Freedom From MACE | 12 months | Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-Month Freedom From Mortality | 12 months | All-cause death |
| 12-Month Freedom From Cardiac death | 12 months | Cardiac death |
| 12-Month Freedom From MI | 12 months | Myocardial infarction |
| 12-Month Freedom From TLR | 12 months | Target lesion revascularisation |
| 12-Month Freedom From Stent Thrombosis | 12 months | Stent thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).Regarding timing, ST was defined as early (\<30 days), late (30 days to 1 year), or too late (\>1 year). |
| 12-Month Freedom From Stroke | 12 months | Stroke |
| 12-Month Freedom From TVR | 12 months | Target vessel revascularisation |
Other
| Measure | Time frame | Description |
|---|---|---|
| 12-Month Freedom From BARC type 2 or above bleeding | 12 months | BARC (Bleeding Academic Research Consortium) type 2 or above bleeding event following the first dose of study medication |
| 12-Month Freedom From Major or minor bleeding | 12 months | Major or minor bleeding defined by TIMI (thrombolysis in myocardial infarction) bleeding criteria |
Countries
China
Outcome results
None listed