Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention

NCT01609647 | Completed Phase 3 DMC

• 1 other identifier: PRAISE-HPR
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

High platelet reactivity unit (PRU) after loading dose clopidogrel in patients undergoing percutaneous coronary intervention (PCI) is related to high risk of short and long term recurrent ischemic events including stent thrombosis. The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in lower risk of short term recurrent ischemic events.

Conditions

Acute Coronary Syndrome

Keywords

High plate reactivity unit after loading dose of clopidogrel

Outcome Measures

Primary Outcomes (1)

• HPR at 24 hours

  Persistently high platelet reactivity after PCI. PRU is measured by methods of VerifyNow device and HPRU is defined as PRU of 240 or more.

  24 hours

Secondary Outcomes (5)

• MACE

  30 days (1 month)

• Bleeding

  30 days (1 month)

• HPRs

  4 hours after PCI, 30 days after PCI

• Periprocedural myocardial infarction

  48 hours after PCI

• Periprocedural myocardial injury

  48 hours after PCI

Study Arms (2)

Prasugrel

EXPERIMENTAL

Reloading with prasugrel 20mg \& followed by administration of 5mg/day for 30 days

Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR

Reloading with clopidogrel 300mg and followed by administration of clopidogrel 75 mg/day for 30 days

Drug: Clopidogrel

Interventions

Prasugrel DRUG

Reloading with prasugrel 20mg and followed by daily administration of prasugrel 5mg for 30 days

Also known as: Effient

Prasugrel

Clopidogrel DRUG

Reloading with clopidogrel 300mg and followed by daily administration of clopidogrel 75mg for 30 days

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute coronary syndrome
• Patients planned to undergo percutaneous transluminal coronary angioplasty
• Patients who agreed to the experimental plan which was permitted by IRB

You may not qualify if:

• Low body weight (\<50kg)
• Urgent PCI for ACS
• Use of glycoprotein IIb/IIIa inhibitor in recent 24hrs or planned to
• History of transient ischemic attack
• History of upper gastrointestinal bleeding in recent 6 months
• Renal dysfunction defined as serum creatinine \> 2.5 mg/dl
• Severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit
• Bleeding tendency
• Anticoagulation treatment including warfarin
• Thrombocytopenia defined by platelet \< 100,000/ml
• Anemia defined by hemoglobin \< 10 g/dl
• Contraindication for study drugs

Sponsors & Collaborators

• Dong-A University: lead

Study Sites (1)

DongA University Hospital

Busan, 602-715, South Korea

Location

Related Publications (2)

• Guo LZ, Kim MH, Shin ES, Ann SH, De Jin C, Cho YR, Park JS, Park K, Park TH, Lee MS, Serebruany VL. Thienopyridine reloading in clopidogrel-loaded patients undergoing percutaneous coronary interventions: The PRAISE study. Int J Cardiol. 2016 Nov 1;222:639-644. doi: 10.1016/j.ijcard.2016.08.027. Epub 2016 Aug 4.

  PMID: 27517654 DERIVED

• Lee DH, Kim MH, Park TH, Park JS, Park K, Zhang HZ, Seo JM, Lee MS. Comparison of prasugrel and clopidogrel reloading on high platelet reactivity in clopidogrel-loaded patients undergoing percutaneous coronary intervention (PRAISE-HPR): a study protocol for a prospective randomized controlled clinical trial. Trials. 2013 Feb 28;14:62. doi: 10.1186/1745-6215-14-62.

  PMID: 23448344 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Moo Hyun Kim, MD

  Director, Regional Clinical Trial Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 1, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

KR (1)