the Effect Between Platelet Reactivation and Antiplatelet Drugs

NCT ID: NCT02198053

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Drug Effect Disorder; Platelet Procoagulant Activity Deficiency

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Ticagrelor2

Ticagrelor with a loading dose of 180mg followed by 90 mg twice per day

No interventions assigned to this group

Ticagrelor1

Ticagrelor with a dose of 90mg followed by 90 mg twice per day .

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

coronary artery disease, percutaneous coronary intervention

Exclusion Criteria

high risk bleeding patient, allergic to the drugs

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

quan li

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LI QUAN, doctor

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

Anzhen Hospital

Beijing, , China

Countries

China

Other Identifiers

azliquan

Identifier Type: -

Identifier Source: org_study_id