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Coronary Artery DiseasePhase 3PRELOAD-LDNCT02070159

Prasugrel With Lower Dose - Loading Dose

A Phase 3 study testing Clopidogrel 600 mg, Prasugrel 30 mg and Prasugrel 60 mg in people with Coronary Artery Disease, 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

Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Clopidogrel 600 mg, Prasugrel 30 mg and Prasugrel 60 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteSouth Korea
Study dates
Dec 2011to Jan 2013
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between 18 and 80 years
  • Stable or unstable angina
  • Planned to undergo elective coronary angiography

Who cannot join

  • Previous history of transient ischemic attack or stroke
  • Intracranial neoplasm
  • Uncontrolled malignant disease
  • History of antiplatelet or anticoagulation treatment within 1 month
  • Contraindication to the study drug
  • Bleeding diathesis
Show all 11Show fewer
  • Hemoglobin < 10 g/dl
  • Platelet count < 100,000/mm3
  • Significant renal insufficiency (glomerular filtration rate <60 mL/min/1.73 m2)
  • Significant hepatic impairment (Serum liver enzyme or bilirubin > 3 times normal limit)
  • Body weight < 50 kg

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: Effect of Lower Loading Dose of Prasugrel Compared With Conventional Loading Dose of Clopidogrel and Prasugrel in Korean Coronary Artery Disease Patients Undergoing Coronary Angiography

Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. The investigators compared the effect of lower loading dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.

Read the detailed description

Although clopidogrel together aspirin has been a backbone of anti-platelet therapy in coronary artery disease patients, clopidogrel has several limitations. It has delayed onset of peak concentration and pharmacodynamic inter-patient response variability resulting in high on-treatment platelet reactivity (HPR). Those demerits are known to be associated with adverse cardiovascular outcomes.

Prasugrel has a more effective metabolism pathway than clopidogrel and exhibits more rapid and potent platelet inhibition. Recent guidelines recommend prasugrel as a first line antiplatelet agent or put precedence over clopidogrel for the patients with acute coronary syndrome. However, there have been concerns of different pharmacodynamic and pharmacokinetic response to prasugrel in East Asian ethnicities.

In addition, lower loading dose of prasugrel exhibited more potent pharmacodynamic effect than clopidogrel 600 mg with comparable efficacy compared to conventional loading dose of prasugrel in healthy Korean subjects.

The investigators compare the antiplatelet effect of lower loading dose of prasugrel 30 mg with conventional loading dose of clopidogrel 600 mg and prasugrel 60 mg in Korean coronary artery disease patients undergoing elective coronary angiography.

Being tested
Clopidogrel 600 mg, Prasugrel 30 mg, Prasugrel 60 mg
Keywords
coronary artery disease, prasugrel, platelet function tests
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Clopidogrel 600 mgDrug

    Also called Plavix 600 mg

    Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel

  • Prasugrel 30 mgDrug

    Also called Effient 30 mg

    Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.

  • Prasugrel 60 mgDrug

    Also called Effient 60 mg

    Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.

Study groups in NCT02070159
Study groupRoleWhat they receive
Clopidogrel 600 mgActive comparatorPatients administer conventional loading dose of clopidogrel 600 mg as active comparators.
Receives: Drug: Clopidogrel 600 mg
Prasugrel 30 mgExperimentalPatients administer lower loading dose of prasugrel 30 mg.
Receives: Drug: Prasugrel 30 mg
Prasugrel 60 mgActive comparatorPatients administer conventional loading dose of prasugrel 60 mg as active comparators.
Receives: Drug: Prasugrel 60 mg

What is being measured

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

  1. Platelet reactivity

    Platelet reactivity was measured using traditional light transmission aggregometry (LTA), VerifyNow (Accumetrics, San Diego, CA, USA), and multiple electrode aggregometry (MEA, Dynabyte Medical, Munich, Germany).

    The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).

    Measured: at 6 hours after administration of study drug. (2 hours for prasugrel groups)

Secondary outcomes (5)

  1. Percent inhibition

    Percent inhibition is calculated using the following fomula: % inhibition = [(baseline reactivity unit - peak reactivity unit) / baseline reactivity unit] × 100.

    Percent inhibition is measured at the time of peak platelet inhibition. The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).

    Measured: at 6 hours after administration of study drug. (2 hours for prasugrel groups)

  2. HPR

    The high platelet reactivity (HPR) was defined as the results of LTA ≥ 48% or ≥ 55%, PRU ≥ 242 or ≥ 275, and result of MEA assay ≥ 37 U or 54 U at the time of peak platelet inhibition The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).

    Measured: at 6 hours after administration of study drug. (2 hours for prasugrel groups)

  3. LPR

    The low platelet reactivity (LPR) was defined as LTA < 12, PRU < 85, MEA < 19 at the time of peak platelet inhibition.

    The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).

    Measured: at 6 hours after administration of study drug. (2 hours for prasugrel groups)

  4. Bleeding event

    Any event related to bleeding including access site bleeding and peri-procedural bleeding based on BARC and ACUITY criteria.

    Measured: 30 days after study drug administration

  5. Adverse reaction

    Any adverse reaction related to study drug.

    Measured: 30 days after study drug administration

Timeline

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

  1. First posted25 Feb 2014 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2012
  4. Study completionJan 2013

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02070159
Sponsor's protocol ID
PRELOAD-LD
Acronym
PRELOAD-LD
Status last verified
Feb 2014
First submitted
8 Feb 2014
Last updated
25 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim MH, Zhang HZ, Jung DK. Pharmacodynamic comparisons for single loading doses of prasugrel (30 mg) and clopidogrel (600 mg) in healthy Korean volunteers. Circ J. 2013;77(5):1253-9. doi: 10.1253/circj.cj-12-0783. Epub 2013 Jan 30.

    PubMed 23363643

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clopidogrel 600 mg, Prasugrel 30 mg and Prasugrel 60 mg in people with Coronary Artery Disease, 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 11 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 25 Feb 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?

Platelet reactivity (time frame: at 6 hours after administration of study drug. (2 hours for prasugrel groups)). 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 NCT02070159, which also lists 1 linked publication.

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 25 Feb 2014.

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