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

Primary Purpose

Coronary Artery Disease, Ticagrelor

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ticagrelor
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Ticagrelor, Clopidogrel, Switching strategy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital of Shenyang Military Region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ticagrelor, 90mg, 12h

Ticagrelor, 90mg, 24h

Ticagrelor, 180mg, 24h

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2018
Last Updated
July 2, 2018
Sponsor
Shenyang Northern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03577652
Brief Title
The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease
Official Title
The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ticagrelor
Keywords
Ticagrelor, Clopidogrel, Switching strategy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor, 90mg, 12h
Arm Type
Experimental
Arm Title
Ticagrelor, 90mg, 24h
Arm Type
Experimental
Arm Title
Ticagrelor, 180mg, 24h
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
Ticagrelor, 90mg, 90mg twice daily
Primary Outcome Measure Information:
Title
Platelet function assessments
Description
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.
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31567375
Citation
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.
Results Reference
derived

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

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