Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509893
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Ticagrelore Alone Post PCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Randomized 6-month Non-inferiority Study to Compare the Safety and Efficacy of TICAgreLor mONotherapy Versus Dual Antiplatelet Therapy in Chronic Coronary Syndrome Patients Post Percutaneous Coronary IntErvention TICALONE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TICALONE
Brief Summary:
After PCI for CCS patients single center double blind randomization will be done and patients will receive aspirin 80 mg and clopidogrel 75 mg versus 90 mg two times daily of ticagrelor for 6 months and MACE will be followed in registry of professor Kojuri cardiology clinic
Detailed Description:
An interventional cardiologist will perform angiography with the supervision of a fellow interventional cardiologist Patients who need revascularization will undergo PCI using DES Drug-eluting stent PCI will be performed using the radial or femoral approach to achieve complete revascularization of at least one stenosis with a diameter of 50 All target lesions will be revascularized using the 4th generation DES
Randomization 11 will take place after diagnostic angiography but before stent insertion figure 1 Eligible patients will be divided into two groups the reference group which will get conventional DAPT with aspirin and Clopidogrel 80 mg aspirin once daily and 75mg clopidogrel once daily and the experimental group which will receive ticagrelor monotherapy 90mg twice daily following PCI for six months
Antiplatelet therapy will start before or at the time of PCI Patients will receive a loading dose of assigned drugs 325mg for aspirin 300mg for clopidogrel and 180mg for ticagrelor before stent insertion unless they are already on pre-PCI maintenance therapy with the mentioned drugs
Subjects are randomly assigned a treatment strategy by an interactive web response system
The primary efficacy endpoint is a composite of cardiac death target vessel MI stent thrombosis and the need for revascularization occurring within 6 months of PCI The secondary endpoints are all-cause death occurrence of MACE including stroke ischemic hemorrhagic or unknown MI arrhythmia and each component of the primary endpoint at 6 months
Safety is the third outcome
Randomization 11 will take place after diagnostic angiography but before stent insertion figure 1 Eligible patients will be divided into two groups the reference group which will get conventional DAPT with aspirin and Clopidogrel 80 mg aspirin once daily and 75mg clopidogrel once daily and the experimental group which will receive ticagrelor monotherapy 90mg twice daily following PCI for six months
Antiplatelet therapy will start before or at the time of PCI Patients will receive a loading dose of assigned drugs 325mg for aspirin 300mg for clopidogrel and 180mg for ticagrelor before stent insertion unless they are already on pre-PCI maintenance therapy with the mentioned drugs
Subjects are randomly assigned a treatment strategy by an interactive web response system
The primary efficacy endpoint is a composite of cardiac death target vessel MI stent thrombosis and the need for revascularization occurring within 6 months of PCI The secondary endpoints are all-cause death occurrence of MACE including stroke ischemic hemorrhagic or unknown MI arrhythmia and each component of the primary endpoint at 6 months
Safety is the third outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None