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

Coronary Artery Disease Clinical Trial

— PL-PLATELET  

Official title:

Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03078465
• Other study ID #: NFH20170307
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 20, 2017
• Est. completion date: May 30, 2021

Study information

• Verified date: August 2021
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Ticagrelor
Daily administration of ticagrelor 180mg for 12 months
• Clopidogrel
Daily administration of clopidogrel 150mg for 12 months

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	12-Month Freedom From Major or minor bleeding	Major or minor bleeding defined by TIMI (thrombolysis in myocardial infarction) bleeding criteria	12 months
Primary	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
Secondary	12-Month Freedom From Mortality	All-cause death	12 months
Secondary	12-Month Freedom From Cardiac death	Cardiac death	12 months
Secondary	12-Month Freedom From MI	Myocardial infarction	12 months
Secondary	12-Month Freedom From TLR	Target lesion revascularisation	12 months
Secondary	12-Month Freedom From TVR	Target vessel revascularisation	12 months
Secondary	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
Secondary	12-Month Freedom From Stroke	Stroke	12 months