CREATE. Cardiovascular Risk Evaluation and Attenuation of inflammation by early rosuvastatin TrEatment - CREATE

Phase 1

• Conditions: Patients with chest pain at rest or minimal physical activity of at least 20 minutes duration will be considered for inclusion in this study. To be eligible, patients have to be considered of low risk after being stable during a minimum period of 6 hours in the chest pain unit.

• Registration Number: EUCTR2006-001860-22-IS
• Lead Sponsor: Karl Andersen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-21
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with chest pain at rest or minimal physical activity of at least 20 minutes duration will be considered for inclusion in this study. To be eligible, patients have to be considered of low risk after being stable during a minimum period of 6 hours in the chest pain unit. They have to have at least two negative measurments of troponin T (less than 0.1 mg/ml) drawn from periferal blood at 6 hour intervals. They may or may not have ischemic changes on EKG´s. After observation in the chest pain unit the patients that are considered not to have myocardial infarction or other need for hospital admission will be invited to participate in the study. These patients will be referred for a symptom limited exercise stress tesing on bicycle ergometry at a follow-up visit 1-2 weeks after their initial evaluation. The patients who have elevated hs-CRP levels at the initial visit indicating an increased cardiovascular risk will be randomized to open-label treatment with rosuvastatin 20 mg o.d. or no statin treatment. Patients with a previous history of ischemic heart disease, statin therapy, chronic or acute disease which can involve increased inflammatory activity will be excluded from the study. Blood samples will be collected for measurement of several markers of inflammation at baseline and 3 and 12 months after randomization. At 3 and 12 months clinical re-evalutation will be made at a follow-up visit, new blood samples collected for measurement of inflammatory markers and major adverse clinical events will be recorded.

To be randomized, patients have to fulfill all of the following criteria:
i.Patients considered at low risk of developing myocardial infarction after observation in the chest pain unit by at least two negative measurements of troponin T
ii.No sign of ongoing ischemia at rest
iii.Elevated hs-CRP
iv.Informed consent

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

i.Elevated troponin T within the previous 30 days
ii.Previous history of atherosclerotic disease
iii.Need for hospitalisation due to myocardial instability or infarction
iv.Inability to perform excercise stress test
v.Bundle branch block or pacemaker rhythm precluding evalutation of ischemia
vi.Any condition, acute or chronic that is known to increase levels of inflammatory markers, (i.e. infection, arthritis, iflammatory bowel disease etc.)
vii.Ongoing statin treatment
viii.Patients who after examination turn out to have any other explanation for their chest pain than cardiac disorders

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether 6 months treatment with rosuvastatin (Crestor) 20 mg o.d. compared to no rosuvastatin treatment will lead to:<br>-significant reduction in serum myeloperoxidase (MPO) and hs-CRP levels at 3 and 12 months after randomiszation<br>in low risk patients after discharge from a Univeristy Hospital chest pain unit.;Secondary Objective: To evaluate whether 6 months treatment with rosuvastatin (Crestor) 20 mg o.d. compared to no rosuvastatin treatment will lead to significant reduction in <br>-serum serum amyloid A (SAA)<br>-serum ICAM-1<br>-serum MCP-1<br>-serum IL-8 and IL-6<br>-serum CD40L<br>in low risk patients after discharge from a Univeristy Hospital chest pain unit.;Primary end point(s): i.Primary EP: Suppression of inflammatory markers, hs-CRP and MPO<br>ii.Secondary EP: Major adverse clinical events (MACE: death, myocardial infarction or need for revascularization) at 12 months.<br>iii.Tertiary EP: Suppression of an extensive panel of markers as described above.<br>