NCT05761067

Brief Summary

The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 5 years in patients with severe CAD and iLVSD. Individual patient data from similar national RCTs independently powered for different efficacy endpoints will be pooled, harmonized, and analyzed. The primary endpoint is all-cause mortality.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,800

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
41mo left

Started Sep 2022

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Sep 2022Sep 2029

Study Start

First participant enrolled

September 14, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2029

Last Updated

September 25, 2024

Status Verified

June 1, 2024

Enrollment Period

7 years

First QC Date

January 23, 2023

Last Update Submit

September 23, 2024

Conditions

Coronary Artery DiseaseHeart Failure

Keywords

PCICABG

Outcome Measures

Primary Outcomes (1)

  • Mortality

    All-cause mortality

    7 year

Secondary Outcomes (5)

  • The occurrence of death

    7 Year

  • The occurrence of stroke

    7 year

  • The occurrence of non-procedural myocardial infarction

    7 year

  • The occurrence of failure hospitalization

    7 year

  • The occurrence of coronary revascularization

    7 year

Study Arms (2)

Percutaneous Coronary Intervention (PCI)

EXPERIMENTAL

Patients will be revascularized by PCI

Procedure: Percutaneous Coronary Intervention (PCI)

Coronary artery bypass grafting (CABG)

NO INTERVENTION

Patients will be revascularized by CABG

Interventions

Percutaneous Coronary Intervention (PCI)PROCEDURE

Alternative treatment

Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • LVEF ≤40%
  • Extensive coronary artery disease (typically defined as a British Cardiovascular Intervention Society jeopardy score of ≥6, on a scale from 0 to 12, with higher scores indicating greater extent of disease).

You may not qualify if:

  • Decompensated heart failure requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ ventricular assist device therapy less than 48 hours prior to randomization;
  • Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) indicating the need for surgical repair/replacement;
  • Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy;
  • Pregnancy;
  • Circumstances likely to lead to poor treatment adherence;
  • STEMI within 72 hours;
  • PCI within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep of Cardiology, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Failure

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Björn Redfors, MD, PhD

CONTACT

+46 313421000bjorn.redfors@wlab.gu.se

Mark Petrie, MD, PhD, Professor

CONTACT

+44 141 330 4558Mark.Petrie@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective individual patient meta-analysis of open-label, multicentre randomized trials.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

March 9, 2023

Study Start

September 14, 2022

Primary Completion (Estimated)

September 14, 2029

Study Completion (Estimated)

September 14, 2029

Last Updated

September 25, 2024

Record last verified: 2024-06

Locations

SE(1)