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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02101411
Enrollment
334
Registered
2014-04-02
Start date
2015-01-01
Completion date
2016-10-01
Last updated
2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

APT(Antiplatelet Therapy), HOTPR(High on Treat Platelet Reactivity), PRU(Platelet Reactivity Unit)

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTPRU(Platelet reactivity unit)

measure by VeryfyNow.

Sponsors

Taipei City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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).

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frameDescription
Numbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects24 monthsMACE(major adverse cardiac event) include: death, myocardial infarction, revascularization.

Countries

Taiwan

Participant flow

Participants by arm

ArmCount
Aspirin+Clopidogrel
aspirin 100mg qd+clopidogrel 75mg q...
107
Aspirin+Ticagrelor
aspirin100mg qd+ticagrelor 90mg bid
102
Aspirin+Clopidogrel+Cilostazol
aspirin 100mg qd+clopidogrel 75mg q...
104
Total313

Baseline characteristics

CharacteristicAspirin+TicagrelorAspirin+Clopidogrel+CilostazolAspirin+ClopidogrelTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
19 Participants24 Participants21 Participants64 Participants
Age, Categorical
Between 18 and 65 years
83 Participants80 Participants86 Participants249 Participants
Age, Continuous66.1 years
STANDARD_DEVIATION 13.9
65.2 years
STANDARD_DEVIATION 13.4
65.4 years
STANDARD_DEVIATION 13
65.8 years
STANDARD_DEVIATION 13.2
Region of Enrollment
Taiwan
102 participants104 participants107 participants313 participants
Sex: Female, Male
Female
29 Participants24 Participants33 Participants86 Participants
Sex: Female, Male
Male
73 Participants80 Participants74 Participants227 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
1 / 1071 / 1022 / 104
other
Total, other adverse events
0 / 1070 / 1020 / 104
serious
Total, serious adverse events
1 / 1070 / 1022 / 104

Outcome results

Primary

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

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

Time frame: 24 months

ArmMeasureValue (NUMBER)
Aspirin+ClopidogrelNumbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects1 numbers of participants with MACE
Aspirin+TicagrelorNumbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects1 numbers of participants with MACE
Aspirin+Clopidogrel+CilostazolNumbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects2 numbers of participants with MACE
Comparison: The differences among the three PRU groups (\<85, 85-208,\>208) and MACE rate at 24 months were compared using the Chi-squared test. was recorded.p-value: 0.002Chi-squared
Comparison: The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.p-value: 0.002Chi-squared

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026