Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI (PL-PLATELET)
Primary Purpose
Coronary Artery Disease
Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease
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.
Sites / Locations
- Nanjing First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor
Clopidogrel
Arm Description
Administration of ticagrelor 180mg/day for 12 months.
Administration of clopidogrel 150 mg/day for 12 months
Outcomes
Primary Outcome Measures
12-Month Freedom From MACE
Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis.
Secondary Outcome Measures
12-Month Freedom From Mortality
All-cause death
12-Month Freedom From Cardiac death
Cardiac death
12-Month Freedom From MI
Myocardial infarction
12-Month Freedom From TLR
Target lesion revascularisation
12-Month Freedom From TVR
Target vessel revascularisation
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-Month Freedom From Stroke
Stroke
Full Information
NCT ID
NCT03078465
First Posted
March 7, 2017
Last Updated
August 18, 2021
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03078465
Brief Title
Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Competitive studies were conducted at the same time, and enrollment was suspended.
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Administration of ticagrelor 180mg/day for 12 months.
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Administration of clopidogrel 150 mg/day for 12 months
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
BRILINTA
Intervention Description
Daily administration of ticagrelor 180mg for 12 months
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix, Talcom
Intervention Description
Daily administration of clopidogrel 150mg for 12 months
Primary Outcome Measure Information:
Title
12-Month Freedom From MACE
Description
Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
12-Month Freedom From Mortality
Description
All-cause death
Time Frame
12 months
Title
12-Month Freedom From Cardiac death
Description
Cardiac death
Time Frame
12 months
Title
12-Month Freedom From MI
Description
Myocardial infarction
Time Frame
12 months
Title
12-Month Freedom From TLR
Description
Target lesion revascularisation
Time Frame
12 months
Title
12-Month Freedom From TVR
Description
Target vessel revascularisation
Time Frame
12 months
Title
12-Month Freedom From Stent Thrombosis
Description
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).
Time Frame
12 months
Title
12-Month Freedom From Stroke
Description
Stroke
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
12-Month Freedom From BARC type 2 or above bleeding
Description
BARC (Bleeding Academic Research Consortium) type 2 or above bleeding event following the first dose of study medication
Time Frame
12 months
Title
12-Month Freedom From Major or minor bleeding
Description
Major or minor bleeding defined by TIMI (thrombolysis in myocardial infarction) bleeding criteria
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27894260
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.
Results Reference
background
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Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI
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