the Effect Between Platelet Reactivation and Antiplatelet Drugs

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
quan li, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT02198053
First received: July 21, 2014
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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
Drug Effect Disorder
Platelet Procoagulant Activity Deficiency

Study Type: Observational [Patient Registry]
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:
  • Platelet reactivity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    LTA and TEG used to measure the effect of Platelet reactivity


Biospecimen Retention:   Samples Without DNA

Platelet reactivity


Estimated Enrollment: 74
Study Start Date: May 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 .

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.

  Eligibility

Genders Eligible for Study:   Both
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: quan li, associate chief physician, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02198053     History of Changes
Other Study ID Numbers: azliquan
Study First Received: July 21, 2014
Last Updated: July 22, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014