A randomized, double-blind, parallel-group, placebo-controlled, multinational clinical trial to evaluate the efficacy of Aliskiren and valsartan versus placebo in lowering levels on NT-proBNP in stabilized patients post acute coronary syndromes

• Conditions: Hypertension

• Registration Number: EUCTR2006-001763-36-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Subjects who are hospitalized for ischemic chest discomfort at rest lasting at
least 10 minutes and consistent with cardiac ischemia
• Subjects who are clinically stable may not have any of the following spontaneous
events for 24 hours prior to randomization:
• Recurrent ischemia at rest
• Symptomatic hypotension or hypotension defined as SBP < 90 mmHg
• Acute mitral regurgitation
• Acute ventricular septal defect
• Ventricular fibrillation
• Sustained ventricular tachycardia (>30 seconds)
• Complete heart block
• High grade second degree heart block (e.g. Mobitz Type II)
• New onset atrial fibrillation
2. Final diagnosis of acute coronary syndrome that includes either:
• unstable angina defined as chest discomfort with 1) transient ST segment
deviation at least 0.5 mm in at least two contiguous leads or, 2) documented
coronary artery disease as defined as prior MI or evidence of a coronary
stenosis at least 50% or
• acute myocardial infarction (MI) defined as elevated concentrations of cardiac
troponin I or T, or CK-MB
3. Elevated concentrations of natriuretic peptide (local determination) 3-10 days
(72 -240 hours) after admission for their index event
• NT-proBNP level > 400 pg/ml or BNP level > 80 pg/ml

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For full list, refer to protocol

1. Known or suspected contraindications, including history of allergy or
hypersensitivity to ARBs, renin antagonists, or to drugs with similar chemical
structures.
2. Presence of clinically overt heart failure defined as the presence of rales 1/3 up
both lung fields, chest radiography showing at least moderate pulmonary
venous congestion, or the presence of a third heart sound.
3. Known evidence of left ventricular systolic dysfunction (an ejection fraction <=
40% as determined by echocardiography, nuclear imaging or ventriculography).
4. CABG less than 3 months before randomization.
5. PCI less than 24 hours before randomization.
6. Planned revascularization within 3 months after randomization.
7. New ACEI, ARBs, or aldosterone inhibitor treatment given for more than 24 hours
as part of the index hospitalization.
8. An increase in a chronic dose of ACEI, ARBs, or aldosterone inhibitor treatment
given for more than 24 hours as part of the index hospitalization.
9. Patients on chronic ACEI or ARB therapy for whom therapy with an ACEI or ARB is
clinically required with no reasonable alternative therapy available
10. Estimated creatinine clearance < 45 ml/min (MDRD Calculation).

Study & Design

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