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

NCT ID: NCT03577652

Last Updated: 2018-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2018-01-10

Brief Summary

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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

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Conditions

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Coronary Artery Disease Ticagrelor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor, 90mg, 12h

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor, 90mg, 90mg twice daily

Ticagrelor, 90mg, 24h

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor, 90mg, 90mg twice daily

Ticagrelor, 180mg, 24h

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor, 90mg, 90mg twice daily

Interventions

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Ticagrelor

Ticagrelor, 90mg, 90mg twice daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenyang Northern Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han Yaling, MD

General Hospital of Shenyang Military Region

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Hospital of Shenyang Military Region

Shenyang, Liaoning, China

Site Status

Countries

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China

References

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Yao Y, Wang P, Wang XZ, Zhao X, Zhao W, Zhou TN, Zhang L. Optimal strategy of switching from clopidogrel to ticagrelor in Chinese acute coronary syndrome patients with complicated coronary artery disease: the switching from clopidogrel to ticagrelor (SHIFT-CACS) study. Chin Med J (Engl). 2019 Oct 5;132(19):2292-2299. doi: 10.1097/CM9.0000000000000444.

Reference Type DERIVED
PMID: 31567375 (View on PubMed)

Other Identifiers

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20180621

Identifier Type: -

Identifier Source: org_study_id

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