Recruiting
Phase 2
Phase 3

Ticagrelor vs. Clopidogrel

Sponsor:

First Affiliated Hospital of Harbin Medical University

Code:

NCT03062462

Conditions

Coronary Artery Disease

Clopidogrel, Poor Metabolism of

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Clopidogrel

ticagrelor

Study Details

Brief summary:

With the widespread use of clopidogrel, resistance to clopidogrel has been attracting increasing attention, and emerged as a new challenge adversely affecting patients clinical risk and outcome. Clopidogrel resistance means that blood platelets show little or no response to clopidogrel. It is closely associated with increased risk of serious cardiovascular events, seriously affects the prognosis of patients, and brings difficulties to clinical treatment.

Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. But it is still not very clear that the effect of low-dose ticagrelor on platelet function in patients with clopidogrel resistance and coronary heart disease.

Therefore, we performed this randomized, single-blind clinical trial to observe the effects of low-dose ticagrelor and double standard-dose clopidogrel on platelet aggregation and prognosis in clopidogrel resistance's patients with coronary heart disease.

Conditions

Coronary Artery Disease

Clopidogrel, Poor Metabolism of

Study ID

NCT03062462

Start date

Feb 10, 2017

Status verified date

Feb, 2018

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Jul 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients with oral clopidogrel treatment admitted to hospital within 24 hours or long-term follow-up outpatients with oral clopidogrel treatment;
2. 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% and the percentage of inhibition of ADP-induced platelet aggregation measured by thrombelastogram is not more than 30%;

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: clopidogrel

To observe double standard-dose clopidogrel on platelet aggregation in clopidogrel resistance's patients with coronary heart disease

experimental: ticagrelor

To observe low-dose of ticagrelor on platelet aggregation in clopidogrel resistance's patients with coronary heart disease

Interventions

Clopidogrel

double standard-dose clopidogrel treatment (300 mg loading dose, then 75 mg twice daily) for 5-7 days

ticagrelor

half-dose ticagrelor treatment (90 mg loading dose, then 45 mg twice daily) for 5-7 days

Primary outcome measure

  • The platelet aggregation rate [ Time Frame: up to 7 days ]

Central Contacts and Locations

Central contacts

Guangzhong Liu, PhD

86-451-85555672lgz2700@126.com

Yue Li, PhD

86-451-85555673ly99ly@vip.163.com

Locations

whole blood lumi-aggregometer type 560 VS

Recruiting

Havertown, Pennsylvania, United States, 19083

Contacts

Chongyang Zhang, MM

1330640@qq.com

More Information

Sponsor

First Affiliated Hospital of Harbin Medical University

Last update posted

May 7, 2018

Last verified

Feb, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by First Affiliated Hospital of Harbin Medical University on 2018-05-07.