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PRU(Platelet Reactivity Unit)NCT02101411

Platelet Reactivity (High On-Treatment Platelet Reactivity) as Guidance for APT (Antiplatelet Therapy) Adjustment After PCI (Percutaneous Coronary Intervention)

An observational study of PRU(Platelet Reactivity Unit) and APT(Antiplatelet Therapy), run by Taipei City Hospital at 1 site in Taiwan.

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

Since thrombus formation is a very complex procedure in vivo, platelet function testing methods in vitro might only reflect the degree of inhibition of platelet from a certain level, which do't reflect the functional status of platelets in vivo adequately. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
PRU(Platelet reactivity unit)
How many people
334 participants
Where
1 siteTaiwan
Study dates
1 Jan 2015to 1 Oct 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: stable angina who received routine dual antiplatelet agents therapy.

Who may be able to join

  • 1 under DAPT (dual antiplatelet therapy) of stable angina patients for elective stent implantation.
  • 2. DAPT 24 hours, 7d and 30d after treatment PRU (platelet activity units) values. (Drug unresponsive patients was defined as PRU> 235).

Who cannot join

  • 1.Not suitable for the treatment of patients with DAPT. (Active peptic ulceration or bleeding) 2 patients of aspirin, clopidogrel, ticagrelor, cilostazol medication intolerance.
  • 3 contraindications for aspirin, clopidogrel, ticagrelor, cilostazol drug usage (such as heart failure patients not suitable for use cilostazol).

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Taipei City Hospital

    Taipei

Other trials in Taiwan

About this study

Since thrombus formation is a very complex procedure in vivo, platelet function testing methods in vitro might only reflect the degree of inhibition of platelet from a certain level, which do't reflect the functional status of platelets in vivo adequately. There are a variety of signal transduction pathways involved in the formation of platelet activation and thrombosis. Gurbel et al. first reported individuals with variability on clopidogrel treatment response in 2003, and proposed the concept of clopidogrel resistance. Different patients received the same dose of aspirin or other anti -platelet drug such as clopidogrel , due to various reasons bound to lack some patients antithrombotic efforts to increase the incidence of thrombotic events , while another part of the patient easily understood antithrombotic excessive bleeding events, " antithrombotic individualized treatment , " according to differences in patient against platelet drugs or anticoagulant drug reactions and adjust the treatment plan , is the direction of antithrombotic therapy in the future.

There are a number of studies have shown that patients with no response Clopidogrel , measuring the relationship between high platelet reactivity and clinical adverse ischemic events displayed between platelet activity . However, there is still lack of quantitative threshold high platelet reactivity and the risks associated with the clinical consensus . In addition, there are only limited data support, to measure platelet function -based therapy to improve the clinical efficacy of the concept . Over the years, more than 20,000 cases reported in patients with numerous studies confirm that high platelet reactivity after PCI with stent thrombosis , including cardiovascular events , including an increased risk of significant correlation . Pharmacodynamic analysis GRVITAS trial showed significantly lower platelet reactivity associated with a lower risk of adverse cardiovascular events . Brar in more than 3000 cases of patients published in JACC Meta-analysis showed that "high platelet reactivity " of patients whose cardiovascular death, heart attack and stent thrombosis occurred more than twice the rate of " non-high platelet reactivity " patients .

Read more

Two new anti-platelet drugs (Prasugrel and Ticagrelor) in several recent randomized trials have considerable persuasive , and has included some guidance in the current guidelines. Ticagrelor even more than Prasugrel in pharmacodynamic studies more effectively inhibit platelet , and has a lower risk of bleeding. Cilostazol is an old drug , mostly for the treatment of intermittent claudication , in recent years there are also some testing and coronary stents prevent restenosis after angioplasty , however, so far , there is little direct comparison Cilostazol and Ticagrelor related articles .

We designed this test , in addition to testing for high yellow people treat DAPT (dual anti-platelet therapy) under the platelet reactivity (high on-treatment platelet reactivity) ratio , this population of patients with ticagrelor instead for a month or cilostazol treatment after its platelet reactivity changes and compare between the two groups , and even track six months after the bleeding and adverse cardiovascular events rate? Through this test we can compare the treatment for patients with high platelet reactivity of what strategies more appropriate.

Being tested
PRU(Platelet reactivity unit)

What participants receive

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

  • PRU(Platelet reactivity unit)Diagnostic test

    Also called Platelet reactivity unit

    measure by VeryfyNow.

Study groups in NCT02101411
Study groupRoleWhat they receive
clopidogreltreated with cloopidogrel
Receives: Diagnostic Test: PRU(Platelet reactivity unit)
ticagrelortreated with ticagrelor
Receives: Diagnostic Test: PRU(Platelet reactivity unit)
cilostazoltreated with clopidogrel+cilostazol
Receives: Diagnostic Test: PRU(Platelet reactivity unit)

What is being measured

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

  1. Numbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects

    MACE(major adverse cardiac event) include: death, myocardial infarction, revascularization.

    Measured: 24 months

Timeline

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

  1. First posted2 Apr 2014 (estimated)
  2. Study start1 Jan 2015
  3. Primary completion1 May 2016
  4. Study completion1 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02101411
Sponsor's protocol ID
TCHIRB-1011207-E-F
Status last verified
Apr 2017
First submitted
28 Mar 2014
Last updated
22 Nov 2019
Data monitoring committee
Yes

Publications

  • Chen YC, Lin FY, Lin YW, Cheng SM, Lin RH, Chuang CL, Sheu JS, Chen SM, Chang CC, Tsai CS. DAPT Plus Cilostazol is Better Than Traditional DAPT or Aspirin Plus Ticagrelor as Elective PCI for Intermediate-to-Highly Complex Cases: Prospective, Randomized, PRU-Based Study in Taiwan. Am J Cardiovasc Drugs. 2019 Feb;19(1):75-86. doi: 10.1007/s40256-018-0302-3.

    PubMed 30467686

Questions about this trial

What is this clinical trial studying?

An observational study of PRU(Platelet Reactivity Unit) and APT(Antiplatelet Therapy), run by Taipei City Hospital at 1 site in Taiwan.

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 2 inclusion and 2 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 22 Nov 2019. 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 Taiwan. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Numbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects (time frame: 24 months). 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 NCT02101411, 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 22 Nov 2019.

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