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The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques (PREDICT Trial)
Phase 4
Waitlist Available
Research Sponsored by General University Hospital, Prague
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* stable angina pectoris
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the patients will be followed in the study for one year.
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
* The prediction of extent and risk profile of coronary atherosclerosis based on clinical evaluation and non-invasive techniques. * Detailed analysis of plaque volume, plaque composition, risk plaque features and shear stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel reconstruction. * Prediction of changes in coronary arteries based on changes in non-invasive examinations. * Examination of WSS influence on atherosclerosis development and changes of WSS during lipid lowering therapy.
Eligible Conditions
- Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the patients will be followed in the study for one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the patients will be followed in the study for one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The prediction of plaque volume and plaque composition.
Secondary study objectives
Prediction of changes in plaque volume and plaque composition
Side effects data
From 2018 Phase 4 trial • 12 Patients • NCT030746308%
genital fungal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adverse Events
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: RosuvastatinExperimental Treatment1 Intervention
All patients will be using rosuvastatin 40 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
FDA approved
Find a Location
Who is running the clinical trial?
Ministry of Health, Czech RepublicOTHER_GOV
24 Previous Clinical Trials
39,579 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
1,240 Patients Enrolled for Coronary Artery Disease
Czech Ministry of EducationOTHER_GOV
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
200 Patients Enrolled for Coronary Artery Disease
Loyola University ChicagoOTHER
21 Previous Clinical Trials
13,028 Total Patients Enrolled
University of IowaOTHER
471 Previous Clinical Trials
894,601 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
782 Patients Enrolled for Coronary Artery Disease
General University Hospital, PragueLead Sponsor
54 Previous Clinical Trials
71,906 Total Patients Enrolled