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Acute Coronary SyndromePhase 3PRAISE-HPRNCT01609647

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

A Phase 3 study testing Prasugrel and Clopidogrel in people with Acute Coronary Syndrome, run by Dong-A University at 1 site in South Korea.

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

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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Prasugrel and Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteSouth Korea
Study dates
Sep 2012to Dec 2014
Phase
Phase 3
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • DongA University Hospital

    Busan, 602-715

Other trials in South Korea

About this study

Official title: Comparison of Prasugrel and Clopidogrel Reloading on High Platelet Reactivity in Clopidogrel-loaded Patients Undergoing Percutaneous Coronary Intervention

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.

Read the detailed description

Dual antiplatelet therapy with acetylsalicyclic acid (ASA) and additional clopidogrel is now standard regimen for the prevention of recurrent ischemic events in patients who undergo PCI.

But decreased effect of clopidogrel in a group of patients was reported and they are known to be associated with high risk of recurrent ischemic event. Decreased effect of clopidogrel is mainly resulted from decreased function to metabolite prodrug, clopidogrel to active form of drug.

Prasugrel, newer thienopyridine has been recently developed and showed advantages to clopidogrel. Prasugrel is known to have shorter onset time to achieve steady state level than clopidogrel and constant pharmacologic effect regardless of patient diversity.

High PRU after loading dose clopidogrel in patients undergoing PCI is known to be related to increased risk of short and long term recurrent ischemic events including stent thrombosis. Prasugrel has been reported to be effective in reducing platelet reactivity in patients showing resistance to clopidogrel and high PRU.

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 reduced risk of short term recurrent ischemic events.

The investigators plan to include 70 acute coronary syndrome patients who are planned to undergo PCI and show high platelet reactivity. Most patients with ACS administer loading dose of ASA and clopidogrel as soon as they are assumed to be ACS.

The investigators plan to perform platelet reactivity test by VeryfyNow (VN) before PCI and enroll patients with high PRU defined by 235 or more. They are to randomly administered additional 300mg of clopidogrel or 20mg of prasugrel.

Being tested
Prasugrel, Clopidogrel
Keywords
High plate reactivity unit after loading dose of clopidogrel
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • PrasugrelDrug

    Also called Effient

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

  • ClopidogrelDrug

    Also called Plavix

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

Study groups in NCT01609647
Study groupRoleWhat they receive
PrasugrelExperimentalReloading with prasugrel 20mg \& followed by administration of 5mg/day for 30 days
Receives: Drug: Prasugrel
ClopidogrelActive comparatorReloading with clopidogrel 300mg and followed by administration of clopidogrel 75 mg/day for 30 days
Receives: Drug: Clopidogrel

What is being measured

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

  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.

    Measured: 24 hours

Secondary outcomes (5)

  1. MACE

    Major adverse cardiovascular events consist of cardiac death, myocardial infarction, stroke, stent thrombosis, cardiac enzyme (CRP, CK-MB, Troponin-I)

    Measured: 30 days (1 month)

  2. Bleeding

    Major, minor or minimal bleeding defined by TIMI(thrombolysis in myocardial infarction) bleeding criteria

    Measured: 30 days (1 month)

  3. HPRs

    Persistently high platelet reactivity 4 hours and 30 days after PCI. PRU is measured by methods of VerifyNow device and HPRU is defined as PRU of 240 or more.

    Measured: 4 hours after PCI, 30 days after PCI

  4. Periprocedural myocardial infarction

    Cardiac troponin value is >5x99th percentile upper reference plus either (1) evidence of prolonged ischaemic chest pain (>20min) or (2) ischaemic ST changes or new pathological Q waves, or (3) angiographic evidence of a side branch occlusion, slow-flow or no-reflow, embolization, or (4) imaging evidence of new regional wall motion abnormality.

    Measured: 48 hours after PCI

  5. Periprocedural myocardial injury

    Cardiac troponin (cTn) value is ≤5x99th percentile upper reference limit (URL) after PCI and cTn value was normal before the PCI or cTn value is >5x99th percentile URL in absence of ischaemic chest pain or ST changes, with normal angiographic and imaging findings.

    Measured: 48 hours after PCI

Timeline

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

  1. First posted1 Jun 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01609647
Sponsor's protocol ID
PRAISE-HPR
Acronym
PRAISE-HPR
Status last verified
Dec 2014
First submitted
29 May 2012
Last updated
23 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27517654

  • 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.

    PubMed 23448344

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prasugrel and Clopidogrel in people with Acute Coronary Syndrome, run by Dong-A University at 1 site in South Korea.

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 3 inclusion and 12 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HPR at 24 hours (time frame: 24 hours). 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 NCT01609647, which also lists 2 linked publications.

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 23 Dec 2014; AzTrials last refreshed its copy on 26 Oct 2026.

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