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MIRACL IN CABG - Statins in cardiac surgery. Effect of doses on inflammatory response and early results - MIRACL IN CABG

MIRACL IN CABG - Statins in cardiac surgery. Effect of doses on inflammatory response and early results - MIRACL IN CABG

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005757-30-IT
Enrollment
Unknown
Registered
2007-06-26
Start date
2007-07-30
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Pts with coronary disease undergoing coronary artery bypass graft surgery. MedDRA version: 9.1 Level: LLT Classification code 10028600 Term: Myocardial ischaemia

Interventions

Trade Name: TORVAST Pharmaceutical Form: Tablet INN or Proposed INN: Atorvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80-

Sponsors

AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pts undergoing isolated coronary artery bypass surgery on elective or urgent bases 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

Exclusion criteria: Valvular surgery o concomitant procedures. Emergent surgery. Epathopathies. Myopaties.

Design outcomes

Primary

MeasureTime frame
Primary end point(s): Reduction of postoperative inflammatory response (evaluated by PCR - IL6 and IL10). Reduction of early mortality (30 days) following coronary artery bypass procedures.;Main Objective: To evaluate the influence of various statin doses regimens on the inflammatory response and early results following cardiacs surgery procedures;Secondary Objective: To evaluate effects of statin therapy on mortality and morbidity followin cabg surgery at 6 and 12 months and to evaluate their influence on rehospedalization rate.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 13, 2026