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

Sponsor

Shenyang Northern Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03577652

Collaborator

(none)

108

Enrollment

Location

Arms

Actual Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Ticagrelor	Drug: Ticagrelor	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 10, 2017

Actual Primary Completion Date :

Jan 10, 2018

Actual Study Completion Date :

Jan 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor, 90mg, 12h	Drug: Ticagrelor Ticagrelor, 90mg, 90mg twice daily
Experimental: Ticagrelor, 90mg, 24h	Drug: Ticagrelor Ticagrelor, 90mg, 90mg twice daily
Experimental: Ticagrelor, 180mg, 24h	Drug: Ticagrelor Ticagrelor, 90mg, 90mg twice daily

Arm

Intervention/Treatment

Experimental: Ticagrelor, 90mg, 12h

Drug: Ticagrelor

Ticagrelor, 90mg, 90mg twice daily

Experimental: Ticagrelor, 90mg, 24h

Drug: Ticagrelor

Ticagrelor, 90mg, 90mg twice daily

Experimental: Ticagrelor, 180mg, 24h

Drug: Ticagrelor

Ticagrelor, 90mg, 90mg twice daily

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18-75
Patients with complexity of CAD determined by coronary angiography and implanted stent successfully
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
Agreeing to participate in this trial and signed the written informed consent.

Exclusion Criteria:

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