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The Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage (STOP-IMH)

Primary Purpose

ST Elevation Myocardial Infarction

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Ticagrelor

Aspirin

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria: Clinical and electrocardiographical diagnosis of STEMI Successful PCI (according to the treating physician) of the infarct-related vessel with a modern DES Exclusion Criteria: Known allergy or contraindication for aspirin, ticagrelor or prasugrel. Previous PCI or MI less than 12 months ago Previous cardiac surgery Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. Pregnancy and breast feeding Concurrent use of oral anticoagulants (OAC) The periprocedural use of GPIIb/IIIa inhibitors Planned surgical intervention within 12 months of PCI Creatinine clearance <30mL/min or dialysis PCI of stent thrombosis Suboptimal stent result as judged by the interventional cardiologist. Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).

Sites / Locations

Noordwest Ziekenhuisgroep Alkmaar
Amsterdam UMC
Medisch Spectrum Twente
Medisch Centrum Leeuwarden
RadboudumcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment arm

Control arm

Arm Description

Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.

Outcomes

Primary Outcome Measures

Composite of major adverse cardiac and cerebral events (MACCE)

Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality

Intramyocardial haemorrhage (IMH)

Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post-PCI.

Secondary Outcome Measures

Bleeding complications

Defined as Bleeding Academic Research Consortium (BARC) 2 or greater

All-cause mortality

Platelet reactivity of aspirin measured as Aspirin Reaction Units (ARU) using the VerifyNow test

Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured

Full Information

NCT ID

NCT05986968

First Posted

July 10, 2023

Last Updated

August 3, 2023

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05986968

Brief Title

The Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage

Acronym

STOP-IMH

Official Title

The Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 6, 2023 (Actual)

Primary Completion Date

July 6, 2025 (Anticipated)

Study Completion Date

July 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main goal of this clinical trial is to assess the safety of direct omission of aspirin after Percutaneous Coronary Intervention (PCI) in patients with ST elevation myocardial infarction (STEMI). The secondary objectives are to demonstrate the reduction of intramyocardial haemorrhage and infarct size, which will be measured after 1 week; to compare clinical bleeding outcomes and to compare platelet reactivity and inflammatory response in STEMI patients receiving ticagrelor monotherapy versus dual antiplatelet therapy. Patients will be treated with either ticagrelor monotherapy or dual antiplatelet therapy (aspirin plus ticagrelor) after PCI. They will be compared to see if the omission of aspirin is safe in terms of major adverse cardiac and cerebral events at 13 months follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Intervention Description

Ticagrelor monotherapy for 12 months

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months

Primary Outcome Measure Information:

Title

Composite of major adverse cardiac and cerebral events (MACCE)

Description

Consisting of: myocardial infarction, stent thrombosis, ischemic stroke, cardiovascular mortality / all-cause mortality

Time Frame

13 months

Title

Intramyocardial haemorrhage (IMH)

Description

Size of IMH and infarct determined by Cardiac Magnetic Resonance imaging at day 5-8 post-PCI.

Time Frame

day 5-8 post PCI

Secondary Outcome Measure Information:

Title

Bleeding complications

Description

Defined as Bleeding Academic Research Consortium (BARC) 2 or greater

Time Frame

13 months

Title

All-cause mortality

Time Frame

13 months

Title

Platelet reactivity of aspirin measured as Aspirin Reaction Units (ARU) using the VerifyNow test

Description

Differences in platelet reactivity between ticagrelor monotherapy and ticagrelor + aspirin will be measured

Time Frame

5-8 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Damman, MD, PhD, FESC

Phone

0031243616785

peter.damman@radboudumc.nl

Facility Information:

Facility Name

Noordwest Ziekenhuisgroep Alkmaar

City

Alkmaar

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maurits Dirksen, MD, PhD

Facility Name

Amsterdam UMC

City

Amsterdam

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bimmer Claessen, MD, PhD

Facility Name

Medisch Spectrum Twente

City

Enschede

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clemens Von Birgelen, MD, Prof

Facility Name

Medisch Centrum Leeuwarden

City

Leeuwarden

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pier Woudstra, MD, PhD

Facility Name

Radboudumc

City

Nijmegen

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Damman, MD, PhD, FESC

12. IPD Sharing Statement

Learn more about this trial

The Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage

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