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Optimal Anti-platelet Treatment for Patients With Clopidogrel Low Response (OPTIMAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01955200
Recruitment Status : Unknown
Verified March 2016 by Chunjian Li, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : October 7, 2013
Last Update Posted : March 17, 2016
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The purpose of this study is to determine that for patients who received stent implantation but present low response to regular anti-platelet treatment, whether 1-month intensified anti-platelet treatment by replacing clopidogrel with ticagrelor (TCL) is superior to double dose clopidogrel or adding cilostazol.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Ticagrelor Drug: Clopidogrel Drug: Cilostazol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Anti-Platelet Treatment for Patients With Stent IMplantation And Clopidogrel Low Response: OPTIMAL Study
Study Start Date : October 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensified Anti-platelet Treatment-1
ASA + ticagrelor
Drug: Ticagrelor
(ASA 100mg daily + Ticagrelor 90mg Bid) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
Other Name: Brilinta

Experimental: Intensified Anti-platelet Treatment-2
ASA + double dose clopidogrel
Drug: Clopidogrel
(ASA 100mg daily + Clopidogrel 150mg daily) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
Other Name: Plavix

Experimental: Intensified Anti-platelet Treatment-3
ASA + clopidogrel + cilostazol
Drug: Cilostazol
(ASA 100mg daily + Clopidogrel 75mg daily + Cilostazol 150mg Bid) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
Other Name: Peida

Active Comparator: Regular DAPT (IPA≦60%)
ASA + clopidogrel
Drug: Clopidogrel
(ASA 100mg daily + Clopidogrel 75mg daily) x 12 month.
Other Name: Plavix

Active Comparator: Regular DAPT (IPA>60%)
ASA + clopidogrel
Drug: Clopidogrel
(ASA 100mg daily + Clopidogrel 75mg daily) x 12 month.
Other Name: Plavix




Primary Outcome Measures :
  1. Inhibition of platelet aggregation (IPA) [ Time Frame: 1-month after randomization ]
    Inhibition of platelet aggregation (IPA) in response to 5μM ADP measured by light transmittancy aggregometer (LTA) 1-month after randomization


Secondary Outcome Measures :
  1. Clinical efficacy [ Time Frame: 1-month and 1-year ]
    1-month and 1-year death, non-fatal myocardial infarction, ischemic stroke, revascularization, and stent thrombosis (ARC definition)


Other Outcome Measures:
  1. Bleeding [ Time Frame: 1-month and 1-year ]
    1-month and 1-year minor, moderate, and major bleeding



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Successively recruit all patients who receive stent implantation;
  2. Patient aged >18 years and ≦80 years old;
  3. Signed inform consent.

Exclusion Criteria:

  1. Allergy or intolerance to ASA, clopidogrel or TCL;
  2. Subjects at a high risk of bleeding (e.g. platelet count< 80*109/L, known bleeding diathesis , active peptic ulcer );
  3. Patients who are planning to take warfarin or drugs that potentially could interfere with the anti-platelet effects of ASA (e.g. non-steroidal anti-inflammatory drugs ) , clopidogrel or TCL (e.g. strong CYP3A inhibitors or CYP3A inducers).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955200


Contacts
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Contact: Chunjian Li, Ph.D +86-25-83718836 ext 6018 lijay@njmu.edu.cn
Contact: Dingguo Zhang, Ph.D +86-25-83718836 ext 6018 zhdg0223@126.com

Locations
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China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Fuming Zhang, M.D.    +86-25-83718836 ext 6360    jsphkj@163.com   
Contact: Yi Chai, M.D.    +86-25-83718836 ext 6360    jsphkj@163.com   
Sub-Investigator: Dingguo Zhang, Ph.D         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
National Natural Science Foundation of China
Investigators
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Principal Investigator: Chunjian Li, Ph.D The First Affiliated Hospital with Nanjing Medical University

Publications:

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Responsible Party: Chunjian Li, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01955200    
Other Study ID Numbers: 001
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Chunjian Li, The First Affiliated Hospital with Nanjing Medical University:
Stent implantation
Clopidogrel low response
Ticagrelor
Cilostazol
Clopidogrel
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cilostazol
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors