Comparison of complete vs single vessel revascularization in patients with coronary artery disease.

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2013-002210-12-ES
• Date of registration: 16/12/2014
• Prospective Registration: Yes
• Primary sponsor: Population Health Research Institute
• Public title: Comparison of complete vs single vessel revascularization in patients with coronary artery disease.
• Scientific title: A randomized, comparative effectiveness study of complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction - COMPLETE
• Date of first enrolment: 17/12/2014
• Target sample size: 3900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002210-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: blinded assessment of outcomes; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Malaysia, Mexico, New Zealand, Norway, Poland, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: José Luis Lopez Sendón
• Affiliation: José Luis Lopez Sendón

• Name: José Luis Lopez Sendón
• Affiliation: José Luis Lopez Sendón

Key inclusion & exclusion criteria

Inclusion criteria:
1. Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after initiation of fibrinolysis AND
2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:
(i) at least 70% diameter stenosis (visual estimation) or
(ii) at least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ? 0.80
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1950
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1950

Exclusion criteria:
1. Planned revascularization of non-culprit lesion
2. Planned surgical revascularization
3. Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
4. Any factor precluding 5 year follow-up
5. Prior Coronary Artery Bypass Graft (CABG) Surgery


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Effectiveness study of complete versus culprit-only revascularization strategies to treat multi vessel disease after primary PCI for STEMI

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: TICAGRELOR
Product Name: Ticagrelor
Pharmaceutical Form: Tablet
INN or Proposed INN: TICAGRELOR
CAS Number: 274693-27-5
Current Sponsor code: TICAGRELOR
Other descriptive name: TICAGRELOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-

Trade Name: Aspirina
Product Name: Acido acetilsalicilico
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
Other descriptive name: ACETYLSALICYLIC ACID
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 75-100

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: until death or new event

Secondary Objective: 1. To determine whether complete revascularization reduces the composite of CV death, new MI or ischemia-driven revascularization
2. To determine whether the initial strategy of complete revascularization improves angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Frequency Scale, and health-related quality of life, as assessed by the EQ-5D Quality of Life scale at 6 months and 5 year/final follow up compared to baseline.

Main Objective: To determine whether, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of multi-vessel revascularization involving staged PCI using drug eluting stents of all suitable non-infarct related artery lesions is superior to a strategy of culprit lesion only revascularization in reducing the composite outcome of CV death or new MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.

Primary end point(s): Cardiovascular death or new myocardial infarction

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 5 YEARS

Secondary end point(s): 1. Composite of CV death, new MI or ischemia-driven revascularization.
2. Changes in Angina Status as per Seattle Angina Questionnaire Angina Frequency Scale and changes in health-related quality of life from baseline, at 6 months and 5 year/final visit, based on the EQ-5D Quality of Life Scale.

Secondary ID(s)

COMPLETE-2013-05-01

Source(s) of Monetary Support

Population Health Research Institute

Ethics review

Status: Approved
Approval date:
Contact: