Delaying progression of arterial disease

Intervention of carotid atherosclerotic plaque progression in individuals with low to intermediate coronary heart disease risk, the ICAPP study - ICAPP

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003457-15-IS

Enrollment

350

Registered

2017-03-13

Start date

2017-06-20

Completion date

Unknown

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Interventions

Trade Name: Rosuvastatin Krka Product Name: Rosuvastatin Krka Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: 55-70 2. Presence of carotid plaque determined using ultra sound 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 175 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 175

Exclusion criteria

Exclusion criteria: 1. Prevalent heart disease 2. Use of lipid lowering medication 3. Diabetes mellitus (DM) 4. Known peripheral vascular disease 5. Previous strokes 6. Intolerance to rosuvastatin

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify, by applying a novel risk calculator, individuals with low or moderate risk of developing coronary heart disease but high risk of having carotid plaque and introducing rosuvastatin treatment to slow down progression of the atherosclerosis measured as carotid atherosclerotic plaque.;Secondary Objective: reduction of consequences of atherosclerosis such as MI, stroke, and CABG, PCI;Primary end point(s): measure progression of atherosclerosis with total plaque area changes ;Timepoint(s) of evaluation of this end point: after two years, after four years	—

Measure

Time frame

Main Objective: To identify, by applying a novel risk calculator, individuals with low or moderate risk of developing coronary heart disease but high risk of having carotid plaque and introducing rosuvastatin treatment to slow down progression of the atherosclerosis measured as carotid atherosclerotic plaque.;Secondary Objective: reduction of consequences of atherosclerosis such as MI, stroke, and CABG, PCI;Primary end point(s): measure progression of atherosclerosis with total plaque area changes ;Timepoint(s) of evaluation of this end point: after two years, after four years

—

Secondary

Measure	Time frame
Secondary end point(s): clinical outcomes : MI, CABG, PCI, stroke and hospitalization due to cardiovascular disease;Timepoint(s) of evaluation of this end point: every three months	—

Countries

Iceland

Contacts

Public ContactIcelandic Heart Association

Icelandic Heart Association

v.gudnason@hjarta.is

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026