NCT03672097

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

Completed Phase 4 Results posted Last updated 12 November 2021

What this trial tests

Phase 4 trial testing Prasugrel in Acute Coronary Syndrome (ACS) in 204 participants. Completed in 19 August 2020.

Timeline

16 October 2018

Primary endpoint
19 August 2020

19 August 2020

Quick facts

Lead sponsor	Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	204
Start date	16 October 2018
Primary completion	19 August 2020
Estimated completion	19 August 2020
Sites	10 locations across Taiwan

Drugs / interventions tested

• Prasugrel (PRASUGREL) — full drug profile →

Conditions studied

• Acute Coronary Syndrome (ACS) — all drugs for Acute Coronary Syndrome (ACS) →

Sponsor

Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company

Who can join

20 and older, any sex, with Acute Coronary Syndrome (ACS). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1 Primary · 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.

Group	Value	95% CI
Prasugrel	-18.2	± 48.1

Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2 Primary · 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

Group	Value	95% CI
Prasugrel	4

Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1 Secondary · Baseline up to Week 4 post-maintenance dose prasugrel treatment period

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

Baseline

Group	Value	95% CI
Prasugrel	23

Week 4

Group	Value	95% CI
Prasugrel	6

Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1 Secondary · 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.

Group	Value	95% CI
Prasugrel	7.2	± 20.4

Number of Participants With Adverse Events of Special Interest During Period 1 Secondary · 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

Any major bleeding adverse events (AE)

Group	Value	95% CI
Prasugrel	0

Any minor bleeding AE

Group	Value	95% CI
Prasugrel	1

Any clinically relevant bleeding AE

Group	Value	95% CI
Prasugrel	2

Any MACE, Cardiovascular death

Group	Value	95% CI
Prasugrel	0

Any MACE, Non-fatal myocardial infarction

Group	Value	95% CI
Prasugrel	0

Any MACE, Non-fatal stroke

Group	Value	95% CI
Prasugrel	0

Any MACE, Stent thrombosis

Group	Value	95% CI
Prasugrel	0

Any MACE, Revascularization

Group	Value	95% CI
Prasugrel	0

Number of Participants With Adverse Events of Special Interest During Period 2 Secondary · 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 dire

Any major bleeding AE

Group	Value	95% CI
Prasugrel	4

Any minor bleeding AE

Group	Value	95% CI
Prasugrel	12

Any clinically relevant bleeding AE

Group	Value	95% CI
Prasugrel	4

Any MACE, Cardiovascular death

Group	Value	95% CI
Prasugrel	0

Any MACE, Non-fatal myocardial infarction

Group	Value	95% CI
Prasugrel	2

Any MACE, Non-fatal stroke

Group	Value	95% CI
Prasugrel	0

Any MACE, Stent thrombosis

Group	Value	95% CI
Prasugrel	0

Any MACE, Revascularization

Group	Value	95% CI
Prasugrel	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prasugrel

Serious: 28/203 (14%)

Deaths: 1/203

Serious adverse events (31 terms)

Reaction	System	Prasugrel
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—
Angina pectoris	Cardiac disorders	—
Acute myocardial infarction	Cardiac disorders	—
Cardiac failure	Cardiac disorders	—
Hepatitis acute	Hepatobiliary disorders	—
Diarrhoea	Gastrointestinal disorders	—
Duodenal ulcer	Gastrointestinal disorders	—
Gastric ulcer haemorrhage	Gastrointestinal disorders	—
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	—
Cardiac failure acute	Cardiac disorders	—
Cardiac failure congestive	Cardiac disorders	—
Chest pain	General disorders	—
Pyrexia	General disorders	—
Diverticulitis	Infections and infestations	—
Pneumonia	Infections and infestations	—
Road traffic accident	Injury, poisoning and procedural complications	—
Skin abrasion	Injury, poisoning and procedural complications	—
Dizziness	Nervous system disorders	—
Cerebral haemorrhage	Nervous system disorders	—
Tonic convulsion	Nervous system disorders	—
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—
Haematuria	Renal and urinary disorders	—
Hydronephrosis	Renal and urinary disorders	—
Anaemia	Blood and lymphatic system disorders	—

Other adverse events (148 terms — click to expand)

Reaction	System	Prasugrel
Anaemia	Blood and lymphatic system disorders	—
Angina pectoris	Cardiac disorders	—
Ecchymosis	Skin and subcutaneous tissue disorders	—
Chest pain	General disorders	—
Dizziness	Nervous system disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Chest discomfort	General disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	—
Upper respiratory tract infection	Infections and infestations	—
Contusion	Injury, poisoning and procedural complications	—
Haematuria	Renal and urinary disorders	—
Abdominal discomfort	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Dental caries	Gastrointestinal disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—
Oedema peripheral	General disorders	—
Overdose	Injury, poisoning and procedural complications	—
Alanine aminotransferase increased	Investigations	—
Aspartate aminotransferase increased	Investigations	—
Liver function test abnormal	Investigations	—
Hypoaesthesia	Nervous system disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Dermatitis	Skin and subcutaneous tissue disorders	—
Abdominal distension	Gastrointestinal disorders	—
Anal haemorrhage	Gastrointestinal disorders	—
Gastric ulcer	Gastrointestinal disorders	—
Gingival bleeding	Gastrointestinal disorders	—
Upper gastrointestional haemorrhage	Gastrointestinal disorders	—
Acute myocardial infarction	Cardiac disorders	—
Atrial fibrillation	Cardiac disorders	—
Cardiac failure	Cardiac disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Pyrexia	General disorders	—
Conjunctivitis	Infections and infestations	—
Influenza	Infections and infestations	—
Tendon injury	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Upper gastrointestinal haemorrhage, Angina pectoris, Acute myocardial infarction, Cardiac failure, Hepatitis acute, Diarrhoea, Duodenal ulcer, Gastric ulcer haemorrhage.

Data from ClinicalTrials.gov NCT03672097 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy.
   Liu PY, Su CH, Kuo FY, Lee WL, et al · · 2022 · cited 13× · PMID 33813727 · DOI 10.1007/s12928-021-00771-w
2. The developmental journey of therapies targeting purine receptors: from basic science to clinical trials.
   Han S, Suzuki-Kerr H, Vlajkovic SM, Thorne PR. · · 2022 · cited 9× · PMID 36173587 · DOI 10.1007/s11302-022-09896-w
3. A HANC Risk Stratification Score for Antiplatelet Therapy Optimization with Low-Dose Prasugrel in Taiwanese Acute Coronary Syndrome Patients from the Switch Study.
   Lee WL, Wang YC, Su CS, Lee HF, et al · · 2022 · cited 2× · PMID 36440250 · DOI 10.6515/acs.202211_38(6).20220702a