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Completed

NCT Number: NCT03672097

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

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.

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Key information

Conditions

Acute Coronary Syndrome (ACS) Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prasugrel

Drug

Prasugrel, oral tablets, containing 3.75 mg per tablet

Other names: Efient®

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2018
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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