The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease

Not Applicable

Completed

• Conditions: Ticagrelor; Coronary Artery Disease
• Interventions: Drug: Ticagrelor

• Registration Number: NCT03577652
• Lead Sponsor: Shenyang Northern Hospital

Brief Summary

The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-10
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Status Verified: 2018-06
• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Study First Posted: 2018-07-05
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Age between 18-75
2. Patients with complexity of CAD determined by coronary angiography and implanted stent successfully
3. Taking clopidogrel 75mg daily over 5 days or paients never took clopidogrel previously should receive 300-600mg drugs at least 12 hours before coronary angiography
4. Agreeing to participate in this trial and signed the written informed consent.

Exclusion Criteria

1. They contraindicated with ticagrelor (including: allergying to ticagrelor or its active metabolite
2. Concomitanting therapy with a strong cytochrome P-450 3A inhibitor or inducer
3. Previous intracranial haemorrhage or ongoing bleeds
4. Moderate or severe hepatic impairment)
5. Having a previous medication with ticagrelor or long term anticoagulation
6. Having a history of asthma or chronic obstructive pulmonary disease (COPD) and recurrent attacked
7. Having an uncontrolled hypertension>180/110mmHg
8. Having a hemoglobin<100g/L 9.Having a platelet counts<100×10^9/L
9. Having severe renal impairment (clearance<30mL/min)
10. Having a history of hepaein-induced thrombocytopenia (HIT)
11. Having a pregnancy or were during lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor, 90mg, 12h	Ticagrelor	-
Ticagrelor, 180mg, 24h	Ticagrelor	-
Ticagrelor, 90mg, 24h	Ticagrelor	-

Primary Outcome Measures

Name	Time	Method
Platelet function assessments	7 Days	The primary endpoint was the comparations between the three projects for the value changes of maximal platelet aggregation (MPA) measured by Light Transmittance Aggregometry (LTA) at 2 hours after switching strategies.

Trial Locations

Locations (1)

General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, Liaoning, China