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Acute Coronary Syndrome (ACS)Phase 4NCT03672097

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

A Phase 4 study testing Prasugrel in people with Acute Coronary Syndrome (ACS), run by Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company at 10 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Acute Coronary Syndrome (ACS)
What is being tested?
Prasugrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
10 sitesTaiwan
Study dates
16 Oct 2018to 19 Aug 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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%
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  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Taiwan10 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Cheng Hsin General Hospital

    Taipei

  • Mackay Memorial Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan

Other trials in Taiwan

About this study

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

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.

Being tested
Prasugrel
Keywords
Percutaneous Coronary Intervention (PCI), ST elevation myocardial infarction (STEMI), Non-ST elevation myocardial infarction [NSTEMI], Unstable angina (UA), Prasugrel, ACS-PCI
Medical subject headings
Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrasugrelDrug

    Also called Efient®

    Prasugrel, oral tablets, containing 3.75 mg per tablet

Study groups in NCT03672097
Study groupRoleWhat they receive
PrasugrelExperimentalParticipants 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)
Receives: Drug: Prasugrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to Week 4 post-maintenance dose prasugrel treatment period

  2. 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)

    Measured: End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period

Secondary outcomes (4)

  1. Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1

    High On-Treatment Platelet Reactivity (HTPR) was defined as PRU >235.

    Measured: Baseline up to Week 4 post-maintenance dose prasugrel treatment period

  2. 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.

    Measured: Baseline up to Week 4 post-maintenance dose prasugrel treatment period

  3. 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.

    Measured: Baseline up to Week 4 post-maintenance dose prasugrel treatment period

  4. 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.

    Measured: End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start16 Oct 2018
  3. Primary completion19 Aug 2020
  4. Study completion19 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03672097
Sponsor's protocol ID
CS747S-B-A4003
Status last verified
Oct 2021
First submitted
13 Sep 2018
Last updated
12 Nov 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 33813727

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prasugrel in people with Acute Coronary Syndrome (ACS), run by Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company at 10 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03672097, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.

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