Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05491200
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2022-08-02
Brief Title:
Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients
Sponsor:
Research Maatschap Cardiologen Rotterdam Zuid
Organization:
Research Maatschap Cardiologen Rotterdam Zuid
Study Overview
Official Title:
COMPARE STEMI ONE- Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients Treated With OCT-guided vs aNgio-guided completE Revascularization
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The study is a multi-centre Open-label Randomized Controlled 11 trial comparing Prasugrel-based short DAPT 30-45 days followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints
In the subgroup of STEMI patients with MVD a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints
In the subgroup of STEMI patients with MVD a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints
Detailed Description:
Consecutive patients with STEMI planned for pPCI will be screened for eligibility criteria and treated as per standard of care with ASA and Prasugrel 60 mg loading dose The culprit lesion will be treated during the index procedure Non culprit lesions in patients with MVD will be treated during staged procedures in any case last instalment of staged procedures should be scheduled within 15 days after index procedure Complete revascularization of non culprit lesions will be allocated to either OCT- or angio-guided strategy OCT randomization At 30-45 days follow-up after index procedure if inclusion criteria are met patients will be randomized to prasugrel monotherapy or standard DAPT regimen DAPT randomization
The follow-up duration is 35 months after DAPT randomization ie clinical outcomes will be analysed at 11 and 35 months after DAPT randomization
The follow-up duration is 35 months after DAPT randomization ie clinical outcomes will be analysed at 11 and 35 months after DAPT randomization
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?:
None
Is an FDA AA801 Violation?:
None