Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI

Phase 3

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT03078465
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Study Start: 2017-06-20
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor	Administration of ticagrelor 180mg/day for 12 months.
Clopidogrel	Clopidogrel	Administration of clopidogrel 150 mg/day for 12 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 TVR	12 months	Target vessel revascularisation
12-Month Freedom From Stroke	12 months	Stroke
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).

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China