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

Myocardial Infarction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327183
• Other study ID #: BP25619
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2011
• Last updated: November 1, 2016
• Start date: May 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Percutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion

Drug:
• RO4905417
5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
• RO4905417
20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
• placebo
iv infusion, completed at least 1 hour and up to 24 hours before PCI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI		from baseline to 24 hours post PCI	No
Secondary	Change from baseline in troponin I at 8 hours post PCI		from baseline to 8 hours post PCI	No
Secondary	Peak and AUC for troponin I		24 hours post PCI	No
Secondary	Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI		from baseline to 24 hours post PCI	No
Secondary	Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI		from baseline to Day 120 post PCI	No
Secondary	Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI		from baseline to Day 30 post PCI	No
Secondary	Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)		120 days	No