Overview

OPTImal Management of Antithrombotic Agents: OPTIMA-2 Trial

Status:
Completed
Trial end date:
2017-11-28
Target enrollment:
0
Participant gender:
All
Summary
High on-treatment platelet reactivity (HOPR) is associated with increased risk of cardiovascular events in patients undergoing percutaneous coronary intervention (PCI). We sought to investigate the efficacy and safety of 1-month intensified antiplatelet therapies in post-PCI patients with HOPR.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborator:
National Natural Science Foundation of China
Treatments:
Cilostazol
Clopidogrel
Ticagrelor
Ticlopidine
Criteria
Inclusion criteria:

1. Successively recruit all patients who receive stent implantation;

2. Intended use of standard DAPT with the combination of aspirin 100mg once daily and
clopidogrel 75mg once daily for at least 12 months;

3. Patient aged >18 years and ≦80 years old;

4. Signed inform consent.

Exclusion criteria:

1. Allergy or intolerance to study drugs;

2. History of gastrointestinal or intracranial bleeding;

3. Need for anticoagulant therapy;

4. High risk of bleeding (e.g., myelodysplasia, baseline platelet count < 80 × 109/L);

5. Hemoglobin < 90g/L;

6. Active malignancy or life expectancy < 1 year;

7. Patients with other conditions made them unsuitable to be recruited at the discretion
of the investigators.