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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2021-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ticagrelor

Administration of ticagrelor 180mg/day for 12 months.

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Daily administration of ticagrelor 180mg for 12 months

Clopidogrel

Administration of clopidogrel 150 mg/day for 12 months

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Daily administration of clopidogrel 150mg for 12 months

Interventions

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Ticagrelor

Daily administration of ticagrelor 180mg for 12 months

Intervention Type DRUG

Clopidogrel

Daily administration of clopidogrel 150mg for 12 months

Intervention Type DRUG

Other Intervention Names

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BRILINTA Plavix, Talcom

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No