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Trial record 52 of 1050 for:    clopidogrel

Ticagrelor and Clopidogrel on Platelet Aggregation in Clopidogrel Resistance's Patients With CHD

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ClinicalTrials.gov Identifier: NCT03614832
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Brief Summary:

The study sought to observe the effects of optimal dose of ticagrelor(90 mg qd)ticagrelor and double standard-dose clopidogrel on platelet reactivity in coronary heart disease patients with high on-treatment platelet reactivity (HTPR) while on clopidogrel.

HTPR with clopidogrel administration in coronary heart disease (CHD) patients has associated with an increased risk of adverse events. Newer P2Y12 inhibitors ticagrelor (90mg BID) provide stronger platelet inhibition compared with clopidogrel, but a low-dose of ticagrelor (90mg QD) has not been previously studied in Chinese CHD patients with HTPR.


Condition or disease Intervention/treatment Phase
Platelet Reactivity Drug: Ticagrelor 90 mg Drug: Clopidogrel 150 mg Phase 4

Detailed Description:

Dual antiplatelet therapy (DAPT) with aspirin and P2Y12 receptor inhibitor has been the mainstay for the prevention of recurrent ischemic events in ACS patients and in those undergoing PCI. However, clopidogrel shows major individual variation in its antiplatelet effect in association with an increased incidence of ischemic events and stent thrombosis in patients with High on-treatment platelet reactivity (HTPR). There are several possible mechanisms of clopidogrel response variability or "resistance". Recently, it has been reported that a marked decrease in platelet response to clopidogrel is highly associated with the CYP2C19*2 loss-of-function allele, leading to an adverse prognosis.

Ticagrelor is the first reversibly binding, oral, direct acting P2Y12 receptor antagonist. Increasing studies showed that ticagrelor has a more rapid onset of effect and greater inhibition of platelet aggregation compared with clopidogrel. Recently, it has been reported that low-dose ticagrelor either with 90 mg QD or 45 mg BID, was associated with a more potent antiplatelet effect compared with clopidogrel treatment and once daily dose provided similar antiplatelet effect but favorable effect on optimal platelet inhibition compared with twice daily dose. Hiasa et al. identified that ticagrelor 45 mg twice daily was associated with enhanced inhibition of platelet aggregation (IPA) compared with clopidogrel 75 mg once daily in 118 Japanese patients with stable CAD. In our previous study, the investigators found that half-dose ticagrelor produced similar inhibitory effects on platelet aggregation as standard-dose ticagrelor and exerted significantly stronger effects than clopidogrel in patients with ACS and one-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than clopidogrel in patients with stable CAD. Furthermore, standard-dose ticagrelor (180mg loading dose [LD], then 90mg twice daily) has a significant increase in the risk of bleeding and incidence rate of dyspnea, and that higher discontinuation rates due to adverse effects compared to clopidogrel. A recent study demonstrated that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in healthy Chinese volunteers compared with Caucasian subjects. Notably, poor drug metabolism of clopidogrel is more common in Asian populations compared with other international regions, due to the prevalence of CYP2C19 reduced-function alleles. The data suggested that a low dose of ticagrelor might be more appropriate for Chinese patients. Therefore, the optimal dose of ticagrelor for Chinese patients with HTPR is increasingly urgent.

So the objectives of this clinical study were to evaluate the effects of optimal dose of ticagrelor(90 mg qd)ticagrelor and double standard-dose clopidogrel on platelet reactivity in Chinese CHD patients with HTPR.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Optimal Dose of Ticagrelor(90 mg qd)and Double Standard-dose Clopidogrel on Platelet Aggregation in Clopidogrel Resistance's Patients With Coronary Heart Disease
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Ticagrelor 90 mg
To observe low-dose of ticagrelor(90 mg once daily oral)on platelet aggregation in clopidogrel resistance's patients with coronary heart disease.
Drug: Ticagrelor 90 mg
half-dose ticagrelor treatment (90 mg loading dose, then 90 mg once daily) for 1 week.

Active Comparator: Clopidogrel 150 mg
To observe double standard-dose clopidogrel (150 mg once daily oral)on platelet aggregation in clopidogrel resistance's patients with coronary heart disease.
Drug: Clopidogrel 150 mg
double standard-dose clopidogrel treatment (150 mg loading dose, then 150 mg once daily) for 1 week.




Primary Outcome Measures :
  1. The plateletinhibition ratio. [ Time Frame: up to 7 days ]
    Thromboelastography (TEG) was used to measure platelet inhibition ratio.


Secondary Outcome Measures :
  1. The platelet aggregation ratio. [ Time Frame: up to 7 days ]
    Light transmission aggregometry method was used to measure platelet aggregation



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with coronary heart disease (CHD) ;
  2. Patients with high on-treatment platelet reactivity (HTPR) while on clopidogrel. Meet the one standards of the following:

(1) The platelet aggregation rate (PAgR) measured with light transmission aggregometry (LTA) is decreased no more than 10% from baseline level, or PAgR is more than 46%; (2) The percentage of inhibition of ADP-induced platelet aggregation measured by thrombelastogram is not more than 30%; (3) The PRU of inhibition of ADP-induced platelet aggregation measured by VerifyNow >208.

Exclusion Criteria:

1.Severe lung injury; 2.Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, or anticoagulant therapy during the study period; 3.Platelet count <100g/L; 4.Creatinine clearance rate < 30ml/min; 5.Severe liver injury. 6.Diagnosed as respiratory or circulatory instability (cardiac shock, severe congestive heart failure NYHA II-IV or left ventricular ejection fraction < 40%); 7.A history of bleeding tendency; 8.Aspirin, ticagrelor or clopidogrel allergies;

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614832


Contacts
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Contact: Guangzhong Liu, PhD 86-451-85555672 lgz2700@126.com
Contact: Yue Li, PhD 86-451-85555673 ly99ly@vip.163.com

Locations
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China, Heilongjiang
the first affiliated hospital of Harbin medical university Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Yue Li, PhD         
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
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Principal Investigator: Yue Li, PhD First Affiliated Hospital of Harbin Medical University

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03614832     History of Changes
Other Study ID Numbers: CHD-201802
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital of Harbin Medical University:
ticagrelor
clopidogrel
platelet reactivity
Additional relevant MeSH terms:
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Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs