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Ticagrelor Monotherapy After Stenting (TIMO)

Primary Purpose

Acute Myocardial Infarction

Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Ticagrelor 90mg
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria:

  1. Men or women at least 18 years old.
  2. Pre- or intra-procedure treatment with ticagrelor.
  3. Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis <50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3.
  4. PCI guided by optical coherence tomography (OCT) with MLDMAX workflow
  5. Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed)
  6. Subject has signed and dated the informed consent form.

Exclusion Criteria:

  1. Planned PCI or any planned surgical intervention within the next 6 months.
  2. Any indication for chronic anticoagulant therapy
  3. Positive COVID-19 antigen or PCR test regardless of symptoms
  4. History of definite stent thrombosis
  5. Left main coronary artery stenting.
  6. Stent thrombosis/restenosis as a culprit lesion.
  7. Visible thrombus on angiography after PCI
  8. Usage of glycoprotein IIb/IIIa inhibitors
  9. Any bifurcation lesion with stenting of both branches.
  10. Any treated lesion within an arterial or venous graft.
  11. Any additional lesion(s) that need(s) a staged revascularization.
  12. Known ejection fraction <30%.
  13. Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
  14. Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months.
  15. Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator).
  16. Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
  17. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception.
  18. Expected inability (by the investigator) to comply with the protocol
  19. Subjects incapable to giving consent personally

Sites / Locations

  • KardiologenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ticagrelor

Arm Description

Ticagrelor 90 mg twice daily for 12 months

Outcomes

Primary Outcome Measures

Major adverse cardiac event
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis.

Secondary Outcome Measures

Number of Participants with bleeding
Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event)
Number of Participants with stent thrombosis or target vessel myocardial infarction
Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)
Number of Participants with myocardial infarction
Any spontaneous myocardial infarction (time-to-event)
Number of Participants that died
All-cause mortality (time-to-event)
Number of Participants with major adverse cardiac event
The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis
Platelet reactivity
Platelet reactivity as assessed by the ADP-test (multiplate).
Platelet reactivity
Platelet reactivity as assessed by the ADP-test (multiplate)

Full Information

First Posted
November 24, 2021
Last Updated
June 7, 2022
Sponsor
Vastra Gotaland Region
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05149560
Brief Title
Ticagrelor Monotherapy After Stenting
Acronym
TIMO
Official Title
Ticagrelor Monotherapy After Coronary Stenting in Patients With Acute Myocardial Infarction - A Prospective Single-centre, Single-arm Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2021 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction. The study is a single-centre, single-arm, prospective phase II study 200 patients who undergo coronary artery stenting due to NSTEMI or STEMI will be included. Primary endpoint (variable): The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.
Detailed Description
A pilot study with 200 subjects undergoing coronary stenting due to NSTEMI or STEMI. All patients will undergo invasive coronary angiography and clinically indicated Percutaneous Coronary Intervention (PCI). PCI will be performed using EES and OCT guidance using the MLDMAX algorithm (Morphology, Length, Diameter, Medial dissection, Apposition, Xpansion). Eligibility criteria will be assessed after completion of PCI. Patients will be given a drug diary to document and as a reminder of the twice daily ticagrelor administration. The Data Safety Monitoring Board (DSMB) will continuously review the outcomes for these patients. After the first 50 patients have been recruited and at least 30 of these patients have reached 3-month follow-up or had the primary outcome, the DSMB will convene to decide whether it is safe to proceed with the study. However, the DSMB will strongly consider early termination of the trial if more than 10 primary endpoint events occur. Patients may be treated with aspirin prior to coronary angiography, as per local treatment guidelines. All patients will be followed for 1 year. After one year, all patients will be treated per the discretion of the treating physician.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single-centre, single-arm, prospective phase II study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 90 mg twice daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 90mg
Intervention Description
All patients will be prescribed ticagrelor as monotherapy
Primary Outcome Measure Information:
Title
Major adverse cardiac event
Description
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis.
Time Frame
within 3 months
Secondary Outcome Measure Information:
Title
Number of Participants with bleeding
Description
Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event)
Time Frame
within 12 months
Title
Number of Participants with stent thrombosis or target vessel myocardial infarction
Description
Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)
Time Frame
within 12 months
Title
Number of Participants with myocardial infarction
Description
Any spontaneous myocardial infarction (time-to-event)
Time Frame
within 12 months
Title
Number of Participants that died
Description
All-cause mortality (time-to-event)
Time Frame
within 12 months
Title
Number of Participants with major adverse cardiac event
Description
The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis
Time Frame
within 12 months.
Title
Platelet reactivity
Description
Platelet reactivity as assessed by the ADP-test (multiplate).
Time Frame
at 24 hours
Title
Platelet reactivity
Description
Platelet reactivity as assessed by the ADP-test (multiplate)
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women at least 18 years old. Pre- or intra-procedure treatment with ticagrelor. Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis <50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3. PCI guided by optical coherence tomography (OCT) with MLDMAX workflow Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed) Subject has signed and dated the informed consent form. Exclusion Criteria: Planned PCI or any planned surgical intervention within the next 6 months. Any indication for chronic anticoagulant therapy Positive COVID-19 antigen or PCR test regardless of symptoms History of definite stent thrombosis Left main coronary artery stenting. Stent thrombosis/restenosis as a culprit lesion. Visible thrombus on angiography after PCI Usage of glycoprotein IIb/IIIa inhibitors Any bifurcation lesion with stenting of both branches. Any treated lesion within an arterial or venous graft. Any additional lesion(s) that need(s) a staged revascularization. Known ejection fraction <30%. Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2). Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months. Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator). Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir) Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception. Expected inability (by the investigator) to comply with the protocol Subjects incapable to giving consent personally
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oskar Angerås, MD, PhD
Phone
+46313427584
Email
oskar.angeras@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Björn Redfors, MD, PhD
Phone
+46313427543
Email
Bjoern.Redfors@wlab.gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oskar Angerås, MD, PhD
Organizational Affiliation
Sahlgrenska Universitetssjukhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kardiologen
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Björn Redfors, PhD, MD
Phone
+46313427543
Email
Bjoern.Redfors@wlab.gu.se
First Name & Middle Initial & Last Name & Degree
Oskar Angerås, PhD, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Ticagrelor Monotherapy After Stenting

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