Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766437
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2021-02-18
Brief Title:
Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTICA
Brief Summary:
Rationale Dual antiplatelet therapy consisting of aspirin and a P2Y12-inhibitor reduces the risk of stent thrombosis myocardial infarction and stroke after coronary stent implantation Inevitably it is also associated with a higher risk of major bleeding Given the advances in stent properties stenting implantation technique and pharmacology it may be possible to treat patients with a single antiplatelet strategy using a potent P2Y12-inhibitor such as prasugrel or ticagrelor
Objective This study will serve as a pilot to investigate the feasibility and safety of a single antiplatelet strategy with prasugrel or ticagrelor prior to during and after stent implantation in 75 patients with non-ST segment elevation acute coronary syndrome
Study design Single-center single arm pilot study with a stopping rule based on the occurrence of definite stent thrombosis
Study population Patients presenting with non-ST segment elevation acute coronary syndrome and a de novo lesions treated with new generation drug-eluting stents with adequate reduction of platelet reactivity according to platelet function testing with VerifyNow and optimal stenting result adjudicated by optical coherence tomography or coronary angiography
Intervention Once daily 10 mg prasugrel or twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 60 mg prasugrel or 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy
Main study endpoint The primary ischemic endpoints is the composite of all-cause mortality myocardial infarction Academic Research Consortium defined stent thrombosis and ischemic stroke at 6 months after percutaneous coronary intervention The primary bleeding outcome is major or minor bleeding defined as Bleeding Academic Research Consortium type 2 3 or 5 bleeding at 6 months after percutaneous coronary intervention
Objective This study will serve as a pilot to investigate the feasibility and safety of a single antiplatelet strategy with prasugrel or ticagrelor prior to during and after stent implantation in 75 patients with non-ST segment elevation acute coronary syndrome
Study design Single-center single arm pilot study with a stopping rule based on the occurrence of definite stent thrombosis
Study population Patients presenting with non-ST segment elevation acute coronary syndrome and a de novo lesions treated with new generation drug-eluting stents with adequate reduction of platelet reactivity according to platelet function testing with VerifyNow and optimal stenting result adjudicated by optical coherence tomography or coronary angiography
Intervention Once daily 10 mg prasugrel or twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 60 mg prasugrel or 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy
Main study endpoint The primary ischemic endpoints is the composite of all-cause mortality myocardial infarction Academic Research Consortium defined stent thrombosis and ischemic stroke at 6 months after percutaneous coronary intervention The primary bleeding outcome is major or minor bleeding defined as Bleeding Academic Research Consortium type 2 3 or 5 bleeding at 6 months after percutaneous coronary intervention
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None