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Cardiovascular DiseasesPhase 3OATNCT00004562

Occluded Artery Trial (OAT)

A Phase 3 study testing Beta adrenergic blockers, Platelet inhibitors and PTCA and stents in people with Cardiovascular Diseases and Heart Diseases, run by NYU Langone Health at 1 site in United States.

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

The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over an… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Beta adrenergic blockers, Platelet inhibitors and PTCA and stents
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,201 participants
Where
1 siteUnited States
Study dates
Sep 1999to Jun 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recent MI (3-28 days) (Day 1 is the calendar day of the MI system onset)
  • MI is defined based on at least 2 of 3 MI criteria confirmed by: 1) ischemic symptoms ≥30 minutes, 2) cardiac serum marker elevation (creatine kinase (CK) ≥2x upper limit of normal and CK-MB elevated above the upper limit of the laboratory normal) or troponin T, or troponin I elevated at least twice the upper limit of normal, 3) EKG: New Q-waves of ≥0.03 sec and/or 1/3 of QRS complex in ≥2 related EKG leads. If cardiac serum markers are elevated (2), any one of the following EKG findings satisfy inclusion criteria; new ST-T changes (ST elevation or depression), new left bundle-branch block (LBBB), loss of R-wave voltage ≥50% in ≥2 related leads or deep T wave inversions ≥3mm in ≥2 leads.
  • TIMI flow 0 or 1 in infarct related artery (IRA)
  • Meets criteria for high risk: EF <50% or site of occlusion is proximal, in left anterior descending (proximal to the second major diagonal branch); large right coronary artery; or circumflex, if supplying large obtuse marginal, and part of inferior wall (i.e., large dominant or co-dominant vessel).

Who cannot join

  • Age <18 y
  • Clinical indication for revascularization defined as follows: rest or low-threshold angina after MI; severe inducible ischemia on low level exercise or pharmacological stress testing (ST decreased ≥2 mm or inability to complete stage 1 or achieve 3-4 metabolic equivalents without angina, hypotension, or reversible perfusion defects in multiple territories or decreased wall motion thickening in >2 segments on echocardiogram); left main coronary disease (≥50% stenosis); or triple-vessel disease (3 major epicardial coronaries with >70% stenoses)
  • Serious illness such as cancer or pulmonary disease that limits 3-year survival
  • Severe renal disease defined as serum creatinine >3.0 mg/dL that markedly increases risk of radiographic contrast
  • Severe valvular disease
  • History of anaphylaxis to radiographic contrast
Show all 18Show fewer
  • Infarct artery too small (reference segment diameter <2.5 mm), target segment within or beyond extreme tortuosity (>90° angulation), or otherwise technically a poor candidate for PCI
  • Chronic occlusion of IRA (seen on angiogram obtained before index MI or angiographic evidence of chronicity, e.g., presence of bridging collaterals)
  • NYHA classes III-IV CHF; patients may be treated for acute heart failure complicating MI and rescreened
  • Cardiogenic shock or sustained hypotension: systolic BP <90 mm Hg or cardiac index <2.2 L/min per m^2
  • LV aneurysm in the same location as index MI and present before index MI
  • Inability to cooperate with the protocol
  • Patient refusal or inability to give informed consent
  • Refusal of patient's physician to allow patient to participate
  • Pregnancy
  • Contraindication to anticoagulation during PCI or to routine antiplatelet therapy after stent implantation
  • Qualifying IRA that has been grafted previously; patients with prior CABG may be enrolled if the IRA was not previously grafted
  • Dilated or hypertrophic cardiomyopathy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York University School of Medicine

    New York, New York, 10010

Other trials in United States

About this study

Official title: Occluded Artery Trial (OAT) - Randomized Comparative Effectiveness Trial of PCI and Medical Therapy Only Post MI

The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over an average 2.9-year follow-up with extended follow up for an average of six years. Long term follow-up of patients were completed in March 2010. Final collection of all regulatory documentation was completed June 2011.

Read the detailed description

BACKGROUND:

The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacologic strategies fail to achieve effective reperfusion in 30 percent or more of patients, and many patients with occluded infarct arteries do not meet current criteria for use of these agents. Early angioplasty, an effective reperfusion method, is available to a small proportion of potentially eligible US acute MI patients. Hence a substantial number of acute MI patients pass the time when reperfusion therapy has any documented benefit (12 - 24 hours) with a persistently closed infarct vessel. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity.

DESIGN NARRATIVE:

Multicenter, randomized, controlled. Patients at 217 clinical sites in the United States, Canada and Internationally were randomly allocated to two treatment arms over five years. One treatment consists of conventional medical management including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification. The other treatment consists of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. Clinical outcomes will be compared using an intention-to-treat analysis. The primary composite endpoint is mortality, recurrent myocardial infarction, and hospitalization for NYHA Class IV congestive heart failure over a three year follow-up. Individual components of the study composite primary endpoint will be compared in the two treatment arms, as will the medical costs of the two treatments and the health-related quality of life. The cost-effectiveness of percutaneous revascularization will be assessed in the study population.

Being tested
Beta adrenergic blockers, Platelet inhibitors, PTCA and stents, ACE Inhibitors
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Heart Failure

What participants receive

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

  • Beta adrenergic blockersDrug

    Also called beta blockers

    Participants will receive beta adrenergic blockers.

  • Platelet inhibitorsDrug

    Also called Antiplatelet drugs

    Participants will receive platelet inhibitors.

  • PTCA and stentsProcedure or surgery

    Also called Percutaneous Transluminal Coronary Angioplasty, and, Stent Placement

    Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.

  • ACE InhibitorsDrug

    Also called angiotensin-converting-enzyme inhibitor

    Participants will receive ACE inhibitors.

Study groups in NCT00004562
Study groupRoleWhat they receive
Optimal Medical Therapy Only (MED)Active comparatorConventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification
Receives: Drug: Beta adrenergic blockers; Drug: Platelet inhibitors; Drug: ACE Inhibitors
Percutaneous Coronary Intervention (PCI)ExperimentalConventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
Receives: Drug: Beta adrenergic blockers; Drug: Platelet inhibitors; Procedure: PTCA and stents; Drug: ACE Inhibitors

What is being measured

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

  1. Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF)

    Number of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.

    Measured: Measured over a maximum 9-year follow-up period - 6 year median

Secondary outcomes (1)

  1. Number of Participants With Secondary Outcomes (Safety Events)

    Number of Participants with Secondary Outcomes (death from any cause, nonfatal MI, class IV HF, cardiac death, occurrence of selected clinical outcomes including stroke, hospitalization for CHF, sustained ventricular tachycardia/ventricular fibrillation, ICD implantation, or the composite end point). Events were centrally adjudicated.

    Measured: Measured over a maximum 9-year follow-up period - 6 year median

Timeline

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

  1. First posted10 Feb 2000 (estimated)
  2. Study startSep 1999
  3. Primary completionMar 2010
  4. Study completionJun 2011

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004562
Sponsor's protocol ID
130
Other IDs
U01HL062509-01A1
Acronym
OAT
Status last verified
Apr 2014
First submitted
9 Feb 2000
Last updated
21 Apr 2014
Data monitoring committee
Yes

Publications

  • Hochman JS, Lamas GA, Knatterud GL, Buller CE, Dzavik V, Mark DB, Reynolds HR, White HD; Occluded Artery Trial Research Group. Design and methodology of the Occluded Artery Trial (OAT). Am Heart J. 2005 Oct;150(4):627-42. doi: 10.1016/j.ahj.2005.07.002.

    PubMed 16209957

  • Skolnick AH, Reynolds HR, White HD, Menon V, Carvalho AC, Maggioni AP, Pearte CA, Gruberg L, Azevedo RE, Schroeder E, Forman SA, Lamas GA, Hochman JS, Dzavik V. Comparison of late results of percutaneous coronary intervention among stable patients </=65 versus >65 years of age with an occluded infarct related artery (from the Occluded Artery Trial). Am J Cardiol. 2012 Mar 1;109(5):614-9. doi: 10.1016/j.amjcard.2011.10.015. Epub 2011 Dec 14.

    PubMed 22172242

  • Deyell MW, Buller CE, Miller LH, Wang TY, Dai D, Lamas GA, Srinivas VS, Hochman JS. Impact of National Clinical Guideline recommendations for revascularization of persistently occluded infarct-related arteries on clinical practice in the United States. Arch Intern Med. 2011 Oct 10;171(18):1636-43. doi: 10.1001/archinternmed.2011.315. Epub 2011 Jul 11.

    PubMed 21747002

  • Udelson JE, Pearte CA, Kimmelstiel CD, Kruk M, Kufera JA, Forman SA, Teresinska A, Bychowiec B, Marin-Neto JA, Hochtl T, Cohen EA, Caramori P, Busz-Papiez B, Adlbrecht C, Sadowski ZP, Ruzyllo W, Kinan DJ, Lamas GA, Hochman JS. The Occluded Artery Trial (OAT) Viability Ancillary Study (OAT-NUC): influence of infarct zone viability on left ventricular remodeling after percutaneous coronary intervention versus optimal medical therapy alone. Am Heart J. 2011 Mar;161(3):611-21. doi: 10.1016/j.ahj.2010.11.020.

    PubMed 21392619

  • Devlin G, Reynolds HR, Mark DB, Rankin JM, Carvalho AC, Vozzi C, Sopko G, Caramori P, Dzavik V, Ragosta M, Forman SA, Lamas GA, Hochman JS. Loss of short-term symptomatic benefit in patients with an occluded infarct artery is unrelated to non-protocol revascularization: results from the Occluded Artery Trial (OAT). Am Heart J. 2011 Jan;161(1):84-90. doi: 10.1016/j.ahj.2010.09.009.

    PubMed 21167338

  • Steigen TK, Buller CE, Mancini GB, Jorapur V, Cantor WJ, Rankin JM, Thomas B, Webb JG, Kronsberg SS, Atchison DJ, Lamas GA, Hochman JS, Dzavik V. Myocardial perfusion grade after late infarct artery recanalization is associated with global and regional left ventricular function at one year: analysis from the Total Occlusion Study of Canada-2. Circ Cardiovasc Interv. 2010 Dec;3(6):549-55. doi: 10.1161/CIRCINTERVENTIONS.109.918722. Epub 2010 Nov 9.

    PubMed 21062997

  • Jorapur V, Lamas GA, Sadowski ZP, Reynolds HR, Carvalho AC, Buller CE, Rankin JM, Renkin J, Steg PG, White HD, Vozzi C, Balcells E, Ragosta M, Martin CE, Srinivas VS, Wharton Iii WW, Abramsky S, Mon AC, Kronsberg SS, Hochman JS. Renal impairment and heart failure with preserved ejection fraction early post-myocardial infarction. World J Cardiol. 2010 Jan 26;2(1):13-8. doi: 10.4330/wjc.v2.i1.13.

    PubMed 20885993

  • Steg PG, Kerner A, Mancini GB, Reynolds HR, Carvalho AC, Fridrich V, White HD, Forman SA, Lamas GA, Hochman JS, Buller CE; OAT Investigators. Impact of collateral flow to the occluded infarct-related artery on clinical outcomes in patients with recent myocardial infarction: a report from the randomized occluded artery trial. Circulation. 2010 Jun 29;121(25):2724-30. doi: 10.1161/CIRCULATIONAHA.109.933200. Epub 2010 Jun 14.

    PubMed 20547926

  • Kruk M, Buller CE, Tcheng JE, Dzavik V, Menon V, Mancini GB, Forman SA, Kurray P, Busz-Papiez B, Lamas GA, Hochman JS. Impact of left ventricular ejection fraction on clinical outcomes over five years after infarct-related coronary artery recanalization (from the Occluded Artery Trial [OAT]). Am J Cardiol. 2010 Jan 1;105(1):10-6. doi: 10.1016/j.amjcard.2009.08.644.

    PubMed 20102883

  • Buller CE, Rankin JM, Carere RG, Buszman PE, Pfisterer ME, Dzavik V, Thomas B, Forman S, Ruzyllo W, Mancini GB, Michalis LK, Abreu PF, Lamas GA, Hochman JS. Percutaneous coronary intervention in the Occluded Artery Trial: procedural success, hazard, and outcomes over 5 years. Am Heart J. 2009 Sep;158(3):408-15. doi: 10.1016/j.ahj.2009.05.035.

    PubMed 19699864

  • Malek LA, Reynolds HR, Forman SA, Vozzi C, Mancini GB, French JK, Dziarmaga M, Renkin JP, Kochman J, Lamas GA, Hochman JS. Late coronary intervention for totally occluded left anterior descending coronary arteries in stable patients after myocardial infarction: Results from the Occluded Artery Trial (OAT). Am Heart J. 2009 Apr;157(4):724-32. doi: 10.1016/j.ahj.2008.12.008.

    PubMed 19332202

  • Dzavik V, Buller CE, Devlin G, Carere RG, Mancini GB, Cantor WJ, Buszman PE, Rankin JM, Vozzi C, Ross JR, Forman S, Barton BA, Lamas AG, Hochman JS. Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial. Catheter Cardiovasc Interv. 2009 May 1;73(6):771-9. doi: 10.1002/ccd.21930.

    PubMed 19309733

  • Mark DB, Pan W, Clapp-Channing NE, Anstrom KJ, Ross JR, Fox RS, Devlin GP, Martin CE, Adlbrecht C, Cowper PA, Ray LD, Cohen EA, Lamas GA, Hochman JS; Occluded Artery Trial Investigators. Quality of life after late invasive therapy for occluded arteries. N Engl J Med. 2009 Feb 19;360(8):774-83. doi: 10.1056/NEJMoa0805151.

    PubMed 19228620

  • Kruk M, Kadziela J, Reynolds HR, Forman SA, Sadowski Z, Barton BA, Mark DB, Maggioni AP, Leor J, Webb JG, Kapeliovich M, Marin-Neto JA, White HD, Lamas GA, Hochman JS. Predictors of outcome and the lack of effect of percutaneous coronary intervention across the risk strata in patients with persistent total occlusion after myocardial infarction: Results from the OAT (Occluded Artery Trial) study. JACC Cardiovasc Interv. 2008 Oct;1(5):511-20. doi: 10.1016/j.jcin.2008.08.007.

    PubMed 19194534

  • Rashba EJ, Lamas GA, Couderc JP, Hollist SM, Dzavik V, Ruzyllo W, Fridrich V, Buller CE, Forman SA, Kufera JA, Carvalho AC, Hochman JS; OAT-EP Investigators. Electrophysiological effects of late percutaneous coronary intervention for infarct-related coronary artery occlusion: the Occluded Artery Trial-Electrophysiological Mechanisms (OAT-EP). Circulation. 2009 Feb 17;119(6):779-87. doi: 10.1161/CIRCULATIONAHA.108.808626. Epub 2009 Feb 2.

    PubMed 19188505

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beta adrenergic blockers, Platelet inhibitors and PTCA and stents in people with Cardiovascular Diseases and Heart Diseases, run by NYU Langone Health at 1 site in United States.

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 18 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF) (time frame: Measured over a maximum 9-year follow-up period - 6 year median). 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 NCT00004562, which also lists 29 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 21 Apr 2014.

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