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Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients

Primary Purpose

ST Elevated Myocardial Infarction, Dual Antiplatelet Therapy

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Prasugrel based short DAPT
Prasugrel based standard DAPT
OCT guided revascularization
Angio guided revascularization
Sponsored by
Research Maatschap Cardiologen Rotterdam Zuid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevated Myocardial Infarction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligibility at index procedure

All STEMI patients who are planned to be treated with PCI:

ST segment elevation myocardial infarction

Chest discomfort suggestive of cardiac ischemia ≥20 min at rest, within 24 h prior to randomization with 1 of the following ECG features:

  • ST segment elevation ≥2 contiguous ECG leads
  • new or presumably new left bundle branch block

In patients with multivessel disease, treatment only of the culprit lesion / target vessel during primary PCI is recommended.

Eligibility at 30-45 days

  • All patients who have provided informed consent
  • Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)
  • No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater).
  • Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of <30% (visually) for all target lesions.
  • Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%.

Exclusion Criteria:

  • Patients on oral anticoagulation
  • Contraindication to P2Y12 inhibitors (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding, fibrin-specific fibrinolytic therapy less than 24 h before randomization, chronic renal insufficiency requiring dialysis, moderate or severe hepatic dysfunction)
  • Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2).
  • Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin)
  • rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital
  • Platelet count <100.000/μL at the time of screening
  • Anemia (hemoglobin <10 g/dL) at the time of screening
  • Comorbidities associated with life expectancy <1 year
  • Pregnancy, giving birth within the last 90 days, or lactation
  • PCI indication for stent thrombosis or previous history of definite stent thrombosis
  • Non-deferrable major surgery on DAPT after PCI
  • Cardiogenic shock
  • Out of hospital cardiac arrest (OHCA)
  • No informed consent

Sites / Locations

  • Segeberger KlinikenRecruiting
  • University hospital Dresden
  • University of Ferrara
  • University San Martino
  • University Federico II
  • University Gemelli
  • Albert Schweitzer ziekenhuisRecruiting
  • Erasmus Medical CenterRecruiting
  • MaasstadziekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Prasugrel-based short DAPT

Prasugrel based standard DAPT

OCT guided non-culprit lesion

Angio guided non-culprit lesion

Arm Description

Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy for 11 months.

Prasugrel-based DAPT for 1 year

Complete revascularization of non culprit lesions guided by OCT

Complete revascularization of non culprit lesions guided by Angio

Outcomes

Primary Outcome Measures

non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel 11 month monotherapy versus standard 12 month DAPT regimen
Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT randomization as composite of all cause death, MI, stroke or BARC bleeding 3 or 5
superiority of an Optical Coherence Tomography (OCT)-guided revascularization completion as compared to a standard angiography-guided revascularization completion.
Post-procedural Minimal Stent Area (MSA)

Secondary Outcome Measures

Composite of MACCE
Composite of the number of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke
BARC type 3 or 5 events
Number of BARC type 3 or 5 events occuring

Full Information

First Posted
August 2, 2022
Last Updated
April 19, 2023
Sponsor
Research Maatschap Cardiologen Rotterdam Zuid
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT05491200
Brief Title
Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Maatschap Cardiologen Rotterdam Zuid
Collaborators
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is a multi-centre, Open-label, Randomized Controlled, 1:1 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.
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 procedure(s), in any case last instalment of staged procedure(s) 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, i.e. clinical outcomes will be analysed at 11 and 35 months after DAPT randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevated Myocardial Infarction, Dual Antiplatelet Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1608 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel-based short DAPT
Arm Type
Experimental
Arm Description
Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy for 11 months.
Arm Title
Prasugrel based standard DAPT
Arm Type
Active Comparator
Arm Description
Prasugrel-based DAPT for 1 year
Arm Title
OCT guided non-culprit lesion
Arm Type
Experimental
Arm Description
Complete revascularization of non culprit lesions guided by OCT
Arm Title
Angio guided non-culprit lesion
Arm Type
Active Comparator
Arm Description
Complete revascularization of non culprit lesions guided by Angio
Intervention Type
Drug
Intervention Name(s)
Prasugrel based short DAPT
Intervention Description
Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus
Intervention Type
Drug
Intervention Name(s)
Prasugrel based standard DAPT
Intervention Description
Prasugrel based DAPT for 1 year
Intervention Type
Device
Intervention Name(s)
OCT guided revascularization
Intervention Description
OCT guided revascularization of the non-culprit lesions
Intervention Type
Device
Intervention Name(s)
Angio guided revascularization
Intervention Description
Angio guided revascularization of the non-culprit lesions
Primary Outcome Measure Information:
Title
non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel 11 month monotherapy versus standard 12 month DAPT regimen
Description
Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT randomization as composite of all cause death, MI, stroke or BARC bleeding 3 or 5
Time Frame
11 months
Title
superiority of an Optical Coherence Tomography (OCT)-guided revascularization completion as compared to a standard angiography-guided revascularization completion.
Description
Post-procedural Minimal Stent Area (MSA)
Time Frame
immediately after the procedure
Secondary Outcome Measure Information:
Title
Composite of MACCE
Description
Composite of the number of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke
Time Frame
3 year
Title
BARC type 3 or 5 events
Description
Number of BARC type 3 or 5 events occuring
Time Frame
1 and 3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligibility at index procedure All STEMI patients who are planned to be treated with PCI: ST segment elevation myocardial infarction Chest discomfort suggestive of cardiac ischemia ≥20 min at rest with 1 of the following ECG features: ST segment elevation ≥2 contiguous ECG leads new or presumably new left bundle branch block In patients with multivessel disease, treatment only of the culprit lesion / target vessel during primary PCI is recommended. Eligibility at 30-45 days All patients who have provided informed consent Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0) No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater). Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of <30% (visually) for all target lesions. Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%. Exclusion criteria Patients on oral anticoagulation Contraindication to P2Y12 inhibitors and/or to Cardioaspirin or to any of the excipients (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding or haemorrhagic diathesis, fibrin-specific fibrinolytic therapy less than 24 h before randomization, severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, history of gastrointestinal perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA grade III or IV), combination with methotrexate at doses of 15 mg/week or more). Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2). Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin), - rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital Platelet count <100.000/μL at the time of screening Anemia (hemoglobin <10 g/dL) at the time of screening Comorbidities associated with life expectancy <1 year Pregnancy, giving birth within the last 90 days, or lactation (see appendix III for women of childbearing potential) PCI indication for stent thrombosis or previous history of definite stent thrombosis Non-deferrable major surgery on DAPT after PCI Cardiogenic shock Out of hospital cardiac arrest (OHCA) unless survivors of ventricular arrythmia with prompt return of spontaneous circulation (ROSC) Patients with severe renal impairment: creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR). Patients participating in another interventional (device of drug trial) within the previous 12 months or patients to whom an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer. No informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valeria Paradies, MD
Phone
+31621620153
Email
paradiesV2@maasstadziekenhuis.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Ria van Vliet
Phone
+31644162844
Email
vlietM@maasstadziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valeria Paradies, MD, PhD
Organizational Affiliation
Research Maatschap Cardiologen Rotterdam Zuid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Segeberger Kliniken
City
Bad Segeberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gert Richardt, PhD
First Name & Middle Initial & Last Name & Degree
Gert Richardt, PhD
Facility Name
University hospital Dresden
City
Dresden
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Linke, PhD
First Name & Middle Initial & Last Name & Degree
Axel Linke
Facility Name
University of Ferrara
City
Ferrara
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianluca Campo, PhD
First Name & Middle Initial & Last Name & Degree
Gianluca Campo, PhD
Facility Name
University San Martino
City
Genova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I. Porto, PhD
First Name & Middle Initial & Last Name & Degree
I. Porto, PhD
Facility Name
University Federico II
City
Napoli
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G. Esposito, PhD
First Name & Middle Initial & Last Name & Degree
G. Esposito, PhD
Facility Name
University Gemelli
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F. Burzotta, PhD
First Name & Middle Initial & Last Name & Degree
F. Burzotta, PhD
Facility Name
Albert Schweitzer ziekenhuis
City
Dordrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Oemrawsingh, PhD
First Name & Middle Initial & Last Name & Degree
Rohit Oemrawsingh
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas van Mieghem, PHD
First Name & Middle Initial & Last Name & Degree
Nicolas v Mieghem
Facility Name
Maasstadziekenhuis
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Paradies
Phone
+31621620153
Email
paradiesV2@maasstadziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Valeria Paradies

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients

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