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.
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
- Conditions the study is for
- PRU(Platelet Reactivity Unit), APT(Antiplatelet Therapy), HOTPR(High on Treat Platelet Reactivity)
- 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.
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.
- Conditions
- PRU(Platelet Reactivity Unit), APT(Antiplatelet Therapy), HOTPR(High on Treat Platelet Reactivity)
- 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 group | Role | What they receive |
|---|---|---|
| clopidogrel | treated with cloopidogrel Receives: Diagnostic Test: PRU(Platelet reactivity unit) | |
| ticagrelor | treated with ticagrelor Receives: Diagnostic Test: PRU(Platelet reactivity unit) | |
| cilostazol | treated 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.
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.
- First posted2 Apr 2014 (estimated)
- Study start1 Jan 2015
- Primary completion1 May 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PRU(Platelet Reactivity Unit)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yueh-Chung, Chen, Taipei City Hospital
- Investigators
- Chen Yueh Chung, chief doctor, Study chair, taipei city hospital, taipei city govermentChen Yueh Chung, chief doctor, Study chair, taipei city hospital, tiapei city goverment
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity (High On-Treatment Platelet Reactivity) as Guidance for APT (Antiplatelet Therapy) Adjustment After PCI (Percutaneous Coronary Intervention)
- ClinicalTrials.gov ID
- NCT02101411
- Acronym / sponsor ID
- TCHIRB-1011207-E-F
- Conditions
- PRU(Platelet Reactivity Unit), APT(Antiplatelet Therapy), HOTPR(High on Treat Platelet Reactivity)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Posted 25 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clopidogrel | – | Diagnostic Test: PRU(Platelet reactivity unit)treated with cloopidogrel |
| ticagrelor | – | Diagnostic Test: PRU(Platelet reactivity unit)treated with ticagrelor |
| cilostazol | – | Diagnostic Test: PRU(Platelet reactivity unit)treated with clopidogrel+cilostazol |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stable angina who received routine dual antiplatelet agents therapy.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRU(Platelet reactivity unit)Also: Platelet reactivity unitmeasure by VeryfyNow. | Diagnostic test | cilostazol, clopidogrel, ticagrelor |
Primary outcome
Numbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects
Time frame: 24 months
MACE(major adverse cardiac event) include: death, myocardial infarction, revascularization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30467686Chen 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.
Related trials for PRU(Platelet Reactivity Unit)
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Recruiting
Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease
Peripheral Arterial Disease (PAD), Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Yueh Chung, chief doctor study chair
taipei city hospital, taipei city goverment
Chen Yueh Chung, chief doctor study chair
taipei city hospital, tiapei city goverment
1 site in 1 country: see every site and its status.
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.