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the Effect Between Platelet Reactivation and Antiplatelet Drugs

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ClinicalTrials.gov Identifier: NCT02198053
Recruitment Status : Unknown
Verified July 2015 by quan li, Beijing Anzhen Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2014
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
quan li, Beijing Anzhen Hospital

Brief Summary:
Different antiplatelet drugs played various role in coronary artery disease. The mechanisms were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel, Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and dyspnea risk, both loading double dose and following second dose time had potential risk and inconvenient in routine clinical work, especially in elective PCI of comparable stable patients in Chinese. The benefit and risk should be balanced in such patients. The investigators supposed loading single dose and followed by second routine time dose was superior to clopidogrel and safer than ticagrelor previously prescribed.

Condition or disease
Drug Effect Disorder Platelet Procoagulant Activity Deficiency

Detailed Description:

All admission patients were divided into two groups, the first group were prescribed loading dose (180 mg) ticagrelor, the second group were prescribed with 90 mg ticagrelor. We measured both platelet activity and platelet reactivity using the LTA at baseline, pre-operation and post-operation. All bleeding or dyspnea events were recorded in hospital period.

Primary endpoints: platelet activity, platelet reactivity using the LTA and safety events were recorded in hospital period.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 74 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Effect of 180 mgTicagrelor Compared With 90 mg Ticagrelor on Platelet Reactivity in Patients Undergoing Elective PCI.
Study Start Date : May 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor
U.S. FDA Resources

Group/Cohort
Ticagrelor2
Ticagrelor with a loading dose of 180mg followed by 90 mg twice per day
Ticagrelor1
Ticagrelor with a dose of 90mg followed by 90 mg twice per day .



Primary Outcome Measures :
  1. Platelet reactivity [ Time Frame: 1 year ]
    LTA and TEG used to measure the effect of Platelet reactivity


Biospecimen Retention:   Samples Without DNA
Platelet reactivity


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese
Criteria

Inclusion Criteria:

coronary artery disease, percutaneous coronary intervention

Exclusion Criteria:

high risk bleeding patient, allergic to the drugs


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): NCT02198053


Locations
China
Anzhen Hospital
Beijing, China, 100029
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
Study Director: LI QUAN, doctor Beijing Anzhen Hospital, Capital Medical University

Responsible Party: quan li, associate chief physician, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02198053     History of Changes
Other Study ID Numbers: azliquan
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs