Clinical trial NCT03078465: Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI
Official title: Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 12-Month Freedom From MACE
timeFrame: 12 months
Secondary outcomes:
measure: 12-Month Freedom From Mortality
timeFrame: 12 months
measure: 12-Month Freedom From Cardiac death
timeFrame: 12 months
measure: 12-Month Freedom From MI
timeFrame: 12 months
measure: 12-Month Freedom From TLR
timeFrame: 12 months
measure: 12-Month Freedom From TVR
timeFrame: 12 months
measure: 12-Month Freedom From Stent Thrombosis
timeFrame: 12 months
measure: 12-Month Freedom From Stroke
timeFrame: 12 months
Other outcomes:
measure: 12-Month Freedom From BARC type 2 or above bleeding
timeFrame: 12 months
measure: 12-Month Freedom From Major or minor bleeding
timeFrame: 12 months
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-Liang Chen, MD
role: STUDY_CHAIR
References:
citation: 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.