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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03577652
Other study ID # 20180621
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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