Expired Study
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Salinas, California 93901


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.


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


Study is Available At:


Original ID:

BP25619


NCT ID:

NCT01327183


Secondary ID:


Study Acronym:


Brief Title:

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


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 INTERVE


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

74 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hoffmann-La Roche


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

532


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Trials
Study Director
Hoffmann-La Roche

Study Dates

Start Date:May 2011
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 1, 2016
First Received Date:March 30, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI
Time Frame:from baseline to 24 hours post PCI
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI
Time Frame:from baseline to Day 120 post PCI
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI
Time Frame:from baseline to Day 30 post PCI
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)
Time Frame:120 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Peak and AUC for troponin I
Time Frame:24 hours post PCI
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in troponin I at 8 hours post PCI
Time Frame:from baseline to 8 hours post PCI
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Percutaneous Coronary Intervention (PCI)
Description:at least 1 hour and up to 24 hours after completion of drug infusion
Arm Name:20 mg/kg RO4905417 before PCI
Intervention Type:Drug
Name:RO4905417
Description:5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Arm Name:5 mg/kg RO4905417 before PCI
Intervention Type:Drug
Name:RO4905417
Description:20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Arm Name:20 mg/kg RO4905417 before PCI
Intervention Type:Drug
Name:placebo
Description:iv infusion, completed at least 1 hour and up to 24 hours before PCI
Arm Name:Placebo before PCI

Study Arms

Study Arm Type:Experimental
Arm Name:20 mg/kg RO4905417 before PCI
Study Arm Type:Experimental
Arm Name:5 mg/kg RO4905417 before PCI
Study Arm Type:Placebo Comparator
Arm Name:Placebo before PCI

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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