Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)

October 15, 2021 updated by: Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company

Phase IV, Non-comparative, Open Label, Multicenter, 28-Week Switching Study of Prasugrel Maintenance Dose From Clopidogrel in Patients With Acute Coronary Syndrome (ACS) Who Underwent a Percutaneous Coronary Intervention (PCI) in Taiwan

This Phase IV, multicenter trial is designed to assess the efficacy of prasugrel in preventing the formation of blood clots in Taiwanese patients with ACS who have been treated with PCI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • Mackay Memorial Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Cheng Hsin General Hospital
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital, Linkou

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is within the age limits and has signed informed consent
  • Weighs at least 50 kg

  • Had a previous diagnosis of ACS (UA, STEMI, or NSTEMI), underwent PCI, and received one of the following treatments:

    • Clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-8 weeks following clopidogrel loading dose (LD) of 300 mg or 600 mg at the time of PCI
    • Ticagrelor MD of 90 mg twice daily (BID) and aspirin 81-100 mg for 1-4 weeks and switching to clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-4 weeks following ticagrelor LD of 180 mg at the time of PCI
    • Clopidogrel MD 75 mg and aspirin 81-100 mg for 2-8 weeks following ticagrelor LD of 180 mg at the time of PCI
    • Or based on investigator's judgment with at least 2 weeks continued use of clopidogrel MD and aspirin 81-100 mg per day before switching to prasugrel and maximum 8 weeks P2Y12 inhibitors MD treatment (prasugrel is not allowed)
  • Is willing and able to abide by the rules of the research unit and study restrictions
  • If a woman of child-bearing potential, has a negative serum pregnancy test at screening
  • Agrees to use at least one method of contraception during the study

Exclusion Criteria:

  • Has active bleeding, significant risk of hemorrhage, or unusual susceptibility to bleed
  • Had previous hemorrhagic stroke at any time, or transient ischemic attack (TIA) or ischemic stroke within 3 months before the informed consent date
  • Has known allergies or hypersensitivity to prasugrel, aspirin, or any of their excipients
  • Has significant hypertension at screening or baseline assessment
  • Has hemoglobin levels <10.5 g/dL or hematocrit levels <30%
  • Has severe left ventricular systolic dysfunction, ejection fraction <30%
  • Is currently undergoing hemodialysis
  • Has evidence of severe hepatic disease or any of the following: serum alanine transaminase or aspartate transaminase ≥3 times the upper limit of normal (ULN); or bilirubin ≥2 times the ULN at screening
  • Has any clinical laboratory result performed at screening that is determined to be detrimental to the patient or could compromise the study as determined the Investigator
  • Has previously participated in this study or in another interventional trial that is not compatible with this study
  • Has evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse as determined by the Investigator

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prasugrel
Participants with ACS who underwent PCI, and were previously taking clopidogrel, receive a maintenance dose (MD) of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS underwent PCI)
Drug: Prasugrel
Prasugrel, oral tablets, containing 3.75 mg per tablet
Other Names:
  • Efient®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1
Time Frame: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
The mean change in the P2Y12 reaction unit value assessed from baseline to the end of the 4-week maintenance dose treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose was analyzed with a paired t-test model. Mean changes (including standard deviations) are presented.
Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2
Time Frame: End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period
All safety events were assessed in the overall Safety Population, regardless of the study period. The incidence of major bleeding events (defined as non-coronary artery bypass grafting [CABG] thrombolysis in myocardial infarction (TIMI) major) after 28 maintenance dose treatment weeks (optional maximum 12-month P2Y12 inhibitor treatment after ACS participants underwent PCI) are reported. Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days)
End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1
Time Frame: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
High On-Treatment Platelet Reactivity (HTPR) was defined as PRU >235.
Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1
Time Frame: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
The mean percentage change in platelet inhibition at the end of the 4-week maintenance dose prasugrel treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose is reported.
Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Number of Participants With Adverse Events of Special Interest During Period 1
Time Frame: Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL.
Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Number of Participants With Adverse Events of Special Interest During Period 2
Time Frame: End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period
All safety events were assessed in the overall Safety Population, regardless of the study period. Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL.
End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS747S-B-A4003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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