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

NCT03672097 | Completed Phase 4 Results

• 1 other identifier: CS747S-B-A4003
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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 Outcomes (4)

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

  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

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

• Number of Participants With Adverse Events of Special Interest During Period 1

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

• Number of Participants With Adverse Events of Special Interest During Period 2

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

Study Arms (1)

Prasugrel

EXPERIMENTAL

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

Interventions

Prasugrel DRUG

Prasugrel, oral tablets, containing 3.75 mg per tablet

Also known as: Efient®

Prasugrel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company: lead

Study Sites (10)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Cheng Hsin General Hospital

Taipei, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 33813727 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Angina, Unstable

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Clinical Study Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: October 16, 2018
• Primary Completion: August 19, 2020
• Study Completion: August 19, 2020
• Last Updated: November 12, 2021
• Results First Posted: November 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

TW (10)