OPTImal Management of Antithrombotic Agents: OPTIMA-5

August 21, 2020 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5

This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.

Study Overview

Status

Unknown

Detailed Description

The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry method(LTA). Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

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

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years.
  • ACS patients.
  • Patients who are treated with ticagrelor and do not tolerate it.
  • Volunteer to participate and sign informed consent.
  • Approved by national regulatory authorities ethics committees.

Exclusion Criteria:

  • Patients who are contraindicated, intolerant or resistant to clopidogrel.
  • History of hematological disease or bleeding tendency; platelet count < 100 × 10^9 cells/L, or > 600 × 10^9 cells/L, hemoglobin < 100 g/L.
  • Abnormal liver or kidney function (ALT > 3 ULN; estimated CrCl < 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease.
  • Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole.
  • Malignancies or other comorbid conditions with life expectancy less than 1 year.
  • Pregnant or lactating woman.

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: clopidogrel-600 mg-12h
clopidogrel 600 mg loading dose (LD) 12 hours after the last maintenance dose(MD) of ticagrelor followed by 75 mg MD daily
Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose(MD)12/24 hours after the last MD of ticagrelor
Other Names:
  • switch
EXPERIMENTAL: clopidogrel-600 mg-24h
clopidogrel 600 mg loading dose (LD) 24 hours after the last maintenance dose(MD) of ticagrelor followed by 75 mg MD daily
Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose(MD)12/24 hours after the last MD of ticagrelor
Other Names:
  • switch
EXPERIMENTAL: clopidogrel-75 mg-12h
clopidogrel 75 mg maintenance dose(MD) 12 hours after the last MD of ticagrelor
Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose(MD)12/24 hours after the last MD of ticagrelor
Other Names:
  • switch
EXPERIMENTAL: clopidogrel-75 mg-24h
clopidogrel 75 mg maintenance dose(MD) 24 hours after the last MD of ticagrelor
Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose(MD)12/24 hours after the last MD of ticagrelor
Other Names:
  • switch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of platelet aggregation between different time points
Time Frame: baseline,4 hours,8 hours,24 hours,48 hours,72 hours
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
baseline,4 hours,8 hours,24 hours,48 hours,72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinical endpoint event
Time Frame: 30 days
Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.
30 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Chunjian Li, Dr, PhD, Principal Investigator

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 (ACTUAL)

June 22, 2020

Primary Completion (ANTICIPATED)

May 30, 2021

Study Completion (ANTICIPATED)

June 30, 2021

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (ACTUAL)

October 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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