A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention - Full Text View

Purpose

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.

Condition	Intervention	Phase
Myocardial Infarction	Drug: RO4905417 Drug: placebo Procedure: Percutaneous Coronary Intervention (PCI)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF 2 DOSES OF RO4905417 (R1512) ADMINISTERED TO PATIENTS WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NON-STEMI) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI [ Time Frame: from baseline to 24 hours post PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in troponin I at 8 hours post PCI [ Time Frame: from baseline to 8 hours post PCI ] [ Designated as safety issue: No ]
Peak and AUC for troponin I [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: No ]
Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI [ Time Frame: from baseline to 24 hours post PCI ] [ Designated as safety issue: No ]
Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI [ Time Frame: from baseline to Day 120 post PCI ] [ Designated as safety issue: No ]
Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI [ Time Frame: from baseline to Day 30 post PCI ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs) [ Time Frame: 120 days ] [ Designated as safety issue: No ]

Enrollment:	532
Study Start Date:	May 2011
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RO4905417 5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI Procedure: Percutaneous Coronary Intervention (PCI) at least 1 hour and up to 24 hours after completion of drug infusion
Experimental: 2	Drug: RO4905417 20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI Procedure: Percutaneous Coronary Intervention (PCI) at least 1 hour and up to 24 hours after completion of drug infusion
Placebo Comparator: 3	Drug: placebo iv infusion, completed at least 1 hour and up to 24 hours before PCI Procedure: Percutaneous Coronary Intervention (PCI) at least 1 hour and up to 24 hours after completion of drug infusion

Eligibility

Ages Eligible for Study:	19 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients, >18 to <75 years of age
Non ST-elevation myocardial infarction
Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
Body mass index (BMI) </= 40 kg/m2

Exclusion Criteria:

Acute ST-elevation myocardial infarction (STEMI)
Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
Percutaneous coronary intervention (PCI) within the past 72 hours
Thrombolytic therapy within the past 7 days
Major surgery within the past 3 months
History of cerebral vascular disease or stroke in the past 3 months
Bleeding disorders
Inadequately controlled severe hypertension
Prior coronary artery bypass graft (CABG) surgery
Decompensated heart failure (oedema and/or rale)
Acute infection at screening or active chronic infection within 3 months prior to PCI
Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
Uncontrolled diabetes mellitus (HbA1C >10%) at baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327183

Show 66 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01327183 History of Changes
Other Study ID Numbers:	BP25619
Study First Received:	March 30, 2011
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013