Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI (PL-PLATELET)
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|ClinicalTrials.gov Identifier: NCT03078465|
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Ticagrelor Drug: Clopidogrel||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1050 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||May 30, 2021|
|Estimated Study Completion Date :||May 30, 2021|
Administration of ticagrelor 180mg/day for 12 months.
Daily administration of ticagrelor 180mg for 12 months
Other Name: BRILINTA
Active Comparator: Clopidogrel
Administration of clopidogrel 150 mg/day for 12 months
Daily administration of clopidogrel 150mg for 12 months
Other Name: Plavix, Talcom
- 12-Month Freedom From MACE [ Time Frame: 12 months ]Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis.
- 12-Month Freedom From Mortality [ Time Frame: 12 months ]All-cause death
- 12-Month Freedom From Cardiac death [ Time Frame: 12 months ]Cardiac death
- 12-Month Freedom From MI [ Time Frame: 12 months ]Myocardial infarction
- 12-Month Freedom From TLR [ Time Frame: 12 months ]Target lesion revascularisation
- 12-Month Freedom From TVR [ Time Frame: 12 months ]Target vessel revascularisation
- 12-Month Freedom From Stent Thrombosis [ Time Frame: 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 [ Time Frame: 12 months ]Stroke
- 12-Month Freedom From BARC type 2 or above bleeding [ Time Frame: 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 [ Time Frame: 12 months ]Major or minor bleeding defined by TIMI (thrombolysis in myocardial infarction) bleeding criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078465
|Contact: Shao-Liang Shao, MDemail@example.com|
|Contact: Jing Kan, MPHfirstname.lastname@example.org|
|Nanjing First Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210006|
|Contact: Shaoliang Chen, MD +86 13605157029 email@example.com|
|Principal Investigator: Shaoliang Chen, MD|
|Sub-Investigator: Junjie Zhang, MD PHD|
|Study Chair:||Shao-Liang Chen, MD||Nanjing First Hospital, Nanjing Medical University|