search
Back to results

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

Primary Purpose

Acute Coronary Syndrome (ACS)

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Prasugrel
Sponsored by
Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome (ACS) focused on measuring Percutaneous Coronary Intervention (PCI), ST elevation myocardial infarction (STEMI), Non-ST elevation myocardial infarction [NSTEMI], Unstable angina (UA), Prasugrel, ACS-PCI

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prasugrel

Arm Description

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)

Outcomes

Primary Outcome Measures

Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1
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.
Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2
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)

Secondary Outcome Measures

Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1
High On-Treatment Platelet Reactivity (HTPR) was defined as PRU >235.
Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1
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.
Number of Participants With Adverse Events of Special Interest During Period 1
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.
Number of Participants With Adverse Events of Special Interest During Period 2
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.

Full Information

First Posted
September 13, 2018
Last Updated
October 15, 2021
Sponsor
Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03672097
Brief Title
Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
August 19, 2020 (Actual)
Study Completion Date
August 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome (ACS)
Keywords
Percutaneous Coronary Intervention (PCI), ST elevation myocardial infarction (STEMI), Non-ST elevation myocardial infarction [NSTEMI], Unstable angina (UA), Prasugrel, ACS-PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Other Intervention Name(s)
Efient®
Intervention Description
Prasugrel, oral tablets, containing 3.75 mg per tablet
Primary Outcome Measure Information:
Title
Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1
Description
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.
Time Frame
Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Title
Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2
Description
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)
Time Frame
End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period
Secondary Outcome Measure Information:
Title
Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1
Description
High On-Treatment Platelet Reactivity (HTPR) was defined as PRU >235.
Time Frame
Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Title
Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1
Description
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.
Time Frame
Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Title
Number of Participants With Adverse Events of Special Interest During Period 1
Description
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.
Time Frame
Baseline up to Week 4 post-maintenance dose prasugrel treatment period
Title
Number of Participants With Adverse Events of Special Interest During Period 2
Description
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.
Time Frame
End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Cheng Hsin General Hospital
City
Taipei
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
33813727
Citation
Liu PY, Su CH, Kuo FY, Lee WL, Wang YC, Lin WS, Chu PH, Lu TM, Lo PH, Lee CH, Lan WR, Huang CL, Tsukiyama S, Yang WC, Cheng LC, Rafael V, Nikolajsen C, Yin WH. Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy. Cardiovasc Interv Ther. 2022 Apr;37(2):269-278. doi: 10.1007/s12928-021-00771-w. Epub 2021 Apr 4. Erratum In: Cardiovasc Interv Ther. 2021 May 22;:
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs