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Myocardial InfarctionPhase 2NCT01327183

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

A Phase 2 study testing Percutaneous Coronary Intervention (PCI) and RO4905417 in people with Myocardial Infarction, run by Hoffmann-La Roche at 66 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 19 to 74 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Percutaneous Coronary Intervention (PCI) and RO4905417
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
532 participants
Where
66 sitesin 4 countries
Study dates
May 2011to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

66 sites in 4 countries.

66 sites in 4 countries

United States35 sites

  • Study site

    Aurora, Illinois, 60504

  • Study site

    Baltimore, Massachusetts, 21287

  • Study site

    Bay City, Michigan, 48708

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Chambersburg, Pennsylvania, 17201

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Fort Wayne, Indiana, 46804

  • Study site

    Houston, Texas, 77024

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Hyannis, Massachusetts, 02601

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Johnson City, New York, 13790

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Littleton, Colorado, 80120

  • Study site

    Los Angeles, California, 90022

  • Study site

    Louisville, Kentucky, 40205

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73109

  • Study site

    Oklahoma City, Oklahoma, 73120

  • Study site

    Petoskey, Michigan, 49770

  • Study site

    Raleigh, North Carolina, 27610

  • Study site

    Ridgewood, New Jersey, 07450

  • Study site

    Saint Paul, Minnesota, 55102

  • Study site

    Salinas, California, 93901

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Springfield, Ohio, 45505

  • Study site

    St. Petersburg, Florida, 33701

  • Study site

    Tampa, Florida, 33613

  • Study site

    Toledo, Ohio, 43606

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Wichita, Kansas, 67214

Other trials in United States

Poland14 sites

  • Study site

    Bydgoszcz, 85-826

  • Study site

    Gdansk, 80-952

  • Study site

    Gdynia, 81-348

  • Study site

    Józefów, 05-410

  • Study site

    Katowice, 40-635

  • Study site

    Krakow, 31-202

  • Study site

    Krakow, 31-501

  • Study site

    Lodz, 91-347

  • Study site

    Starogard Gdański, 83-200

  • Study site

    Torun, 87-100

  • Study site

    Warsaw, 02-637

  • Study site

    Warsaw, 04-628

  • Study site

    Wejherowo, 84-200

  • Study site

    Wroclaw, 50-981

Other trials in Poland

Canada12 sites

  • Study site

    Edmonton, Alberta, T6G1Z1

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    Newmarket, Ontario, L3Y 2R2

  • Study site

    Ottawa, Ontario, K1Y 4W7

  • Study site

    Québec, Quebec, G1V 4G5

  • Study site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Study site

    Toronto, Ontario, M5G 1L7

  • Study site

    Vancouver, British Columbia, V5Z 1L8

  • Study site

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

Netherlands5 sites

  • Study site

    Heerlen, 6419 PC

  • Study site

    Leeuwarden, 8934 AD

  • Study site

    Nijmegen, 6525 GA

  • Study site

    Rotterdam, 3079 DZ

  • Study site

    Tilburg, 5042 AD

Other trials in Netherlands

About this study

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)

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.

Being tested
Percutaneous Coronary Intervention (PCI), RO4905417, placebo
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary Intervention (PCI)Procedure or surgery

    at least 1 hour and up to 24 hours after completion of drug infusion

  • RO4905417Drug

    5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI

  • RO4905417Drug

    20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI

  • placeboDrug

    iv infusion, completed at least 1 hour and up to 24 hours before PCI

Study groups in NCT01327183
Study groupRoleWhat they receive
20 mg/kg RO4905417 before PCIExperimentalNot described
Receives: Procedure: Percutaneous Coronary Intervention (PCI); Drug: RO4905417
5 mg/kg RO4905417 before PCIExperimentalNot described
Receives: Procedure: Percutaneous Coronary Intervention (PCI); Drug: RO4905417
Placebo before PCIPlacebo comparatorNot described
Receives: Procedure: Percutaneous Coronary Intervention (PCI); Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: from baseline to 24 hours post PCI

Secondary outcomes (6)

  1. Change from baseline in troponin I at 8 hours post PCI

    Measured: from baseline to 8 hours post PCI

  2. Peak and AUC for troponin I

    Measured: 24 hours post PCI

  3. Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI

    Measured: from baseline to 24 hours post PCI

  4. Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI

    Measured: from baseline to Day 120 post PCI

  5. Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI

    Measured: from baseline to Day 30 post PCI

  6. Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)

    Measured: 120 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01327183
Sponsor's protocol ID
BP25619
Status last verified
Nov 2016
First submitted
30 Mar 2011
Last updated
2 Nov 2016
Results posted
No

Publications

  • 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.

    PubMed 27852589

  • 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.

    PubMed 23500230

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Percutaneous Coronary Intervention (PCI) and RO4905417 in people with Myocardial Infarction, run by Hoffmann-La Roche at 66 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Poland, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01327183, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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