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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577652
• Other study ID #: 20180621
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: January 10, 2018

Study information

• Verified date: June 2018
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Ticagrelor

Intervention

Drug:
• Ticagrelor
Ticagrelor, 90mg, 90mg twice daily

Locations

Country	Name	City	State
China	General Hospital of Shenyang Military Region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet function assessments	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.	7 Days