Efficacy and Safety Study of Ticagrelor

June 23, 2015 updated by: General Hospital of Chinese Armed Police Forces

The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention

The purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

180 elective percutaneous coronary intervention patients with clopidogrel resistance were randomized to three groups, Group 1:received clopidogrel 75mg qd ;Group 2:received clopidogrel 150mg qd ; Group 3:received ticagrelor 90mg bid after PCI.Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis before PCI,and 3days,7days and 1 month after PCI,respectively.The aim of our study is to compare the efficacy and safety of ticagrelor with clopidogrel

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: yujie wei, doctor
  • Phone Number: 86-10-57976707

Study Locations

  • China
      • Beijing, China, 100039
        • Recruiting
        • General Hospital of Chinese People's Armed Police Forces
        • Contact:
          • yujie wei, doctor
          • Phone Number: 86-10-57976707
        • Principal Investigator:
          • yingping xiao, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.Clinical diagnosis of ACS 2.undergoing PCI 3.with clopidogrel resistance

Exclusion Criteria:

  • 1.any contraindication against the use of clopidogrel and ticagrel 2.Contradiction to aspirin and contrast medium 3.Life expectancy less than 1 year 4.Tumor or inflammatory diseases5. fibrinolytic therapy within 24 hours before randomization 6.a need for oral anticoagulation therapy 7. an increased risk of bradycardia 8.concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer 9.a history of asthma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group 1
Group 1 will be administered with Clopidogrel 75mg daily until the end of the trial
Drug: Clopidogrel
After 600mg loading dose, 75mg or 150mg Qd
Other Names:
  • Plavix
EXPERIMENTAL: group 2
Group 2 will be administered with Clopidogrel 150mg daily until the end of trial
Drug: Clopidogrel
After 600mg loading dose, 75mg or 150mg Qd
Other Names:
  • Plavix
EXPERIMENTAL: group 3
Group 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial
Drug: Ticagrelor
90mg Bid
Other Names:
  • Brilique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRI
Time Frame: post operative 1 month
Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis.And a platelet reactivity index (PRI) was calculated.
post operative 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events(MACEs)
Time Frame: follow-up for 1 month
cardiovascular death,angiographically confirmed stent thrombosis, recurrent acute coronary syndrome defined by the American College of Cardiology/American Heart Association guidelines,and recurrent revascularization by either coronary angioplasty or bypass surgery
follow-up for 1 month
major and minor bleeding
Time Frame: follow-up for 1 month
Major bleeding was defined as intracranial bleeding or clinically-overt bleeding associated with a decrease in hemoglobin of 50 g/L, according to the Thrombolysis inMyocardial Infarction (TIMI) criteria .Minor bleeding was also defined according to TIMI criteria .
follow-up for 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Chinese Armed Police Forces

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (ESTIMATE)

March 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130118 CR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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