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

NCT ID: NCT02101411

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 334 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2016-10-01

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

clopidogrel

treated with cloopidogrel

PRU(Platelet reactivity unit)

Intervention Type: DIAGNOSTIC_TEST

measure by VeryfyNow.

ticagrelor

treated with ticagrelor

PRU(Platelet reactivity unit)

Intervention Type: DIAGNOSTIC_TEST

measure by VeryfyNow.

cilostazol

treated with clopidogrel+cilostazol

PRU(Platelet reactivity unit)

Intervention Type: DIAGNOSTIC_TEST

measure by VeryfyNow.

Interventions

PRU(Platelet reactivity unit)

measure by VeryfyNow.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Platelet reactivity unit

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yueh-Chung, Chen

chief of ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Yueh Chung, chief doctor

Role: STUDY_CHAIR

taipei city hospital, taipei city goverment

Chen Yueh Chung, chief doctor

Role: STUDY_CHAIR

taipei city hospital, tiapei city goverment

Locations

Taipei City Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 30467686 (View on PubMed)

Other Identifiers

TCHIRB-1011207-E-F

Identifier Type: -

Identifier Source: org_study_id