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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention (PCI)
RO4905417
RO4905417
placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

20 mg/kg RO4905417 before PCI

5 mg/kg RO4905417 before PCI

Placebo before PCI

Arm Description

Outcomes

Primary Outcome Measures

Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2011
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01327183
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 INTERVENTION (PCI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
532 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20 mg/kg RO4905417 before PCI
Arm Type
Experimental
Arm Title
5 mg/kg RO4905417 before PCI
Arm Type
Experimental
Arm Title
Placebo before PCI
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention (PCI)
Intervention Description
at least 1 hour and up to 24 hours after completion of drug infusion
Intervention Type
Drug
Intervention Name(s)
RO4905417
Intervention Description
5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Intervention Type
Drug
Intervention Name(s)
RO4905417
Intervention Description
20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
iv infusion, completed at least 1 hour and up to 24 hours before PCI
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline in troponin I at 8 hours post PCI
Time Frame
from baseline to 8 hours post PCI
Title
Peak and AUC for troponin I
Time Frame
24 hours post PCI
Title
Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI
Time Frame
from baseline to 24 hours post PCI
Title
Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI
Time Frame
from baseline to Day 120 post PCI
Title
Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI
Time Frame
from baseline to Day 30 post PCI
Title
Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)
Time Frame
120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Baltimore
State/Province
Massachusetts
ZIP/Postal Code
21287
Country
United States
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z1
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2R2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
St-Charles Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 6J2
Country
Canada
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
City
Bydgoszcz
ZIP/Postal Code
85-826
Country
Poland
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Gdynia
ZIP/Postal Code
81-348
Country
Poland
City
Jozefow
ZIP/Postal Code
05-410
Country
Poland
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
City
Starogard Gdanski
ZIP/Postal Code
83-200
Country
Poland
City
Torun
ZIP/Postal Code
87-100
Country
Poland
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
City
Wejherowo
ZIP/Postal Code
84-200
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
City
Łodz
ZIP/Postal Code
91-347
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27852589
Citation
Stahli BE, Gebhard C, Duchatelle V, Cournoyer D, Petroni T, Tanguay JF, Robb S, Mann J, Guertin MC, Wright RS, L L'Allier P, Tardif JC. Effects of the P-Selectin Antagonist Inclacumab on Myocardial Damage After Percutaneous Coronary Intervention According to Timing of Infusion: Insights From the SELECT-ACS Trial. J Am Heart Assoc. 2016 Nov 16;5(11):e004255. doi: 10.1161/JAHA.116.004255.
Results Reference
derived
PubMed Identifier
23500230
Citation
Tardif JC, Tanguay JF, Wright SR, Duchatelle V, Petroni T, Gregoire JC, Ibrahim R, Heinonen TM, Robb S, Bertrand OF, Cournoyer D, Johnson D, Mann J, Guertin MC, L'Allier PL. Effects of the P-selectin antagonist inclacumab on myocardial damage after percutaneous coronary intervention for non-ST-segment elevation myocardial infarction: results of the SELECT-ACS trial. J Am Coll Cardiol. 2013 May 21;61(20):2048-55. doi: 10.1016/j.jacc.2013.03.003. Epub 2013 Mar 10. Erratum In: J Am Coll Cardiol. 2016 Mar 15;67(10):1261.
Results Reference
derived

Learn more about this trial

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

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