Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI (PL-PLATELET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03078465
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Shaoliang Chen, 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Ticagrelor Drug: Clopidogrel Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ticagrelor
Administration of ticagrelor 180mg/day for 12 months.
Drug: Ticagrelor
Daily administration of ticagrelor 180mg for 12 months
Other Name: BRILINTA

Active Comparator: Clopidogrel
Administration of clopidogrel 150 mg/day for 12 months
Drug: Clopidogrel
Daily administration of clopidogrel 150mg for 12 months
Other Name: Plavix, Talcom




Primary Outcome Measures :
  1. 12-Month Freedom From MACE [ Time Frame: 12 months ]
    Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis.


Secondary Outcome Measures :
  1. 12-Month Freedom From Mortality [ Time Frame: 12 months ]
    All-cause death

  2. 12-Month Freedom From Cardiac death [ Time Frame: 12 months ]
    Cardiac death

  3. 12-Month Freedom From MI [ Time Frame: 12 months ]
    Myocardial infarction

  4. 12-Month Freedom From TLR [ Time Frame: 12 months ]
    Target lesion revascularisation

  5. 12-Month Freedom From TVR [ Time Frame: 12 months ]
    Target vessel revascularisation

  6. 12-Month Freedom From Stent Thrombosis [ Time Frame: 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).

  7. 12-Month Freedom From Stroke [ Time Frame: 12 months ]
    Stroke


Other Outcome Measures:
  1. 12-Month Freedom From BARC type 2 or above bleeding [ Time Frame: 12 months ]
    BARC (Bleeding Academic Research Consortium) type 2 or above bleeding event following the first dose of study medication

  2. 12-Month Freedom From Major or minor bleeding [ Time Frame: 12 months ]
    Major or minor bleeding defined by TIMI (thrombolysis in myocardial infarction) bleeding criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078465


Contacts
Layout table for location contacts
Contact: Shao-Liang Shao, MD +86-25-52208351 chmengx@126.com
Contact: Jing Kan, MPH +86-25-52271398 kanjingok@126.com

Locations
Layout table for location information
China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Shaoliang Chen, MD    +86 13605157029    chmengx@126.com   
Principal Investigator: Shaoliang Chen, MD         
Sub-Investigator: Junjie Zhang, MD PHD         
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
Layout table for investigator information
Study Chair: Shao-Liang Chen, MD Nanjing First Hospital, Nanjing Medical University

Publications:
Layout table for additonal information
Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03078465     History of Changes
Other Study ID Numbers: NFH20170307
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs