Not provided
Not provided
Not provided
Not provided
Competitive studies were conducted at the same time, and enrollment was suspended.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 Î’: 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | Administration of ticagrelor 180mg/day for 12 months. |
|
| Clopidogrel | Active Comparator | Administration of clopidogrel 150 mg/day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Daily administration of ticagrelor 180mg for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12-Month Freedom From MACE | Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12-Month Freedom From Mortality | All-cause death | 12 months |
| 12-Month Freedom From Cardiac death | Cardiac death | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12-Month Freedom From BARC type 2 or above bleeding | BARC (Bleeding Academic Research Consortium) type 2 or above bleeding event following the first dose of study medication | 12 months |
| 12-Month Freedom From Major or minor bleeding |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shao-Liang Chen, MD | Nanjing First Hospital, Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27894260 | Background | Zhang JJ, Gao XF, Ge Z, Tian NL, Liu ZZ, Lin S, Ye F, Chen SL. High platelet reactivity affects the clinical outcomes of patients undergoing percutaneous coronary intervention. BMC Cardiovasc Disord. 2016 Nov 29;16(1):240. doi: 10.1186/s12872-016-0394-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clopidogrel | Drug | Daily administration of clopidogrel 150mg for 12 months |
|
|
| 12-Month Freedom From MI | Myocardial infarction | 12 months |
| 12-Month Freedom From TLR | Target lesion revascularisation | 12 months |
| 12-Month Freedom From TVR | Target vessel revascularisation | 12 months |
| 12-Month Freedom From Stent Thrombosis | 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 months |
| 12-Month Freedom From Stroke | Stroke | 12 months |
Major or minor bleeding defined by TIMI (thrombolysis in myocardial infarction) bleeding criteria
| 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |