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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Ticagrelor Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ticagrelor

Drug

Ticagrelor, 90mg, 90mg twice daily

Primary outcomes

Platelet function assessments

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jul 5, 2018
Registry last updated: Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed