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Unstable AnginaPhase 3NCT00093158

Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS)

A Phase 3 study testing Angiomax (bivalirudin) anticoagulant in people with Unstable Angina and Myocardial Infarction, run by The Medicines Company 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 show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous coronary intervention [PCI]; Arm A): 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Angiomax (bivalirudin) anticoagulant
How many people
13,800 participants
Where
1 siteUnited States
Study dates
Aug 2003to Jan 2007
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be aged >=18 years at the time of randomization.
  • Have symptoms which include at least 10 minutes of angina or anginal equivalent that the investigator believes has a high likelihood of being ischemic in origin within the 24 hours prior to randomization consistent with a diagnosis of Unstable Angina/Non-ST Elevation Myocardial Infarction (UA/NSTEMI) (patients with symptoms atypical for cardiac ischemia should not be enrolled).
  • Meet at least one of the following criteria for UA/NSTEMI:
  • All of the following four features: *Age >= to 65 years; *aspirin taken within the last 7 days; *two or more episodes of angina in the last 24 hours; *three or more of the following risk factors: hypertension, high cholesterol, family history, diabetes, current smoker OR
  • ECG changes: New or presumably new ST-segment depression >=0.1 MV (>=1mm), or transient (<30 minutes) ST-segment elevation >=0.1MV (>=1mm) in at least 2 contiguous leads, OR
  • Abnormal cardiac enzymes within the 24 hours before enrollment defined as elevated troponin I, T or creatine phosphokinase-MB isoenzyme (CPK-MB) level greater than the site's upper limit of normal (ULN) OR
  • History of coronary artery disease with documentation of one of the following: *prior angiography (coronary stenosis of >50%); *prior PCI or Coronary Artery Bypass Grafting (CABG); *prior definite, documented myocardial infarction.
  • Provide written informed consent before initiation of any study related procedures.

Who cannot join

  • Anticipated inability to perform angiography within 72 hours of randomization and anticipated inability to perform any intervention required (PCI or CABG) within the index hospitalization.
  • ST segment elevation of >1 mm in 2 contiguous ECG leads lasting for >30 minutes, or new left bundle branch block, or a clinical syndrome consistent with acute evolving transmural MI requiring immediate thrombolytic or interventional reperfusion therapy.
  • Cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes not responding to intravenous fluids, or requiring intravenous pressor agents or an intra-aortic balloon pump).
  • Bleeding diathesis or any history of hemorrhagic stroke or other intra-cerebral bleed, cerebral arteriovenous malformation, cerebral aneurysm or prior ischemic stroke within the last 2 years, or any prior stroke with residual neurologic deficit. Gastrointestinal or genitourinary bleeding within the last 2-weeks.
  • Platelet count <100,000 cells/mm3 at baseline, or history of heparin induced thrombocytopenia
  • Patients on warfarin or phenprocoumon, unless they can be safely discontinued and the baseline INR is < 1.5 times control.
Show all 23Show fewer
  • Allergy to pork or pork products.
  • Patients who have been started on and received 2 or more doses of low molecular weight heparin for the current admission prior to randomization (patients who have received one dose of low molecular weight heparin may still be enrolled.
  • Patients who have been started on bivalirudin in the 6 hours prior to randomization
  • Thrombolytic therapy or abciximab use within the last 24 hours.
  • Treatment with a GPIIb/IIIa inhibitor at the time of randomization, which cannot be discontinued.
  • Patients on Arixtra (fondaparinux).
  • Absolute contraindication or allergy to:
  • any one of enoxaparin, unfractionated heparin, bivalirudin or aspirin
  • both abciximab and eptifibatide
  • both eptifibatide and tirofiban
  • iodinated contrast which cannot be pre-medicated
  • Contraindications to angiography, including but not limited to severe peripheral vascular disease.
  • Angina from secondary causes.
  • Pregnancy or nursing mothers. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
  • Calculated serum creatinine clearance < 30 mL/min (Determined by the Cockcroft Gault formula: ((140-age in yrs) x weight in kg)/(814.464 x Creatinine in mmol/l) or /(72 x [Creatinine in mg/dL]). For women, multiply by 0.85.
  • Previous enrollment in this study.
  • Patients currently enrolled in another investigational drug study that has not completed the follow-up phase.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cardiovascular Research Foundation

    New York, New York, 10022

Other trials in United States

About this study

Official title: The ACUITY Trial: A Randomized Comparison of Angiomax (Bivalirudin) Versus Heparin (Unfractionated Heparin or Enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary Syndromes Without ST-Segment Elevation

The purpose of this study is to show that, when compared with heparin (enoxaparin or unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the time of percutaneous coronary intervention [PCI]; Arm A):

  1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time of PCI; Arm B) provides non-inferior or superior overall clinical outcomes and
  2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications.
Being tested
Angiomax (bivalirudin) anticoagulant
Keywords
Acute Coronary Syndromes
Medical subject headings
Angina, Unstable, Myocardial Infarction, Acute Disease, Acute Coronary Syndrome

What participants receive

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

  • Angiomax (bivalirudin) anticoagulantDrug

Timeline

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

  1. First posted7 Oct 2004 (estimated)
  2. Study startAug 2003
  3. Study completionJan 2007

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
13,800 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093158
Sponsor's protocol ID
TMC-BIV-02-08
Other IDs
ACUITY
Status last verified
Aug 2007
First submitted
4 Oct 2004
Last updated
21 Aug 2007
Results posted
No

Publications

  • Redfors B, Kirtane AJ, Pocock SJ, Ayele GM, Deliargyris EN, Mehran R, Stone GW, Genereux P. Bleeding Events Before Coronary Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome. J Am Coll Cardiol. 2016 Dec 20;68(24):2608-2618. doi: 10.1016/j.jacc.2016.09.957.

    PubMed 27978944

  • Giacoppo D, Madhavan MV, Baber U, Warren J, Bansilal S, Witzenbichler B, Dangas GD, Kirtane AJ, Xu K, Kornowski R, Brener SJ, Genereux P, Stone GW, Mehran R. Impact of Contrast-Induced Acute Kidney Injury After Percutaneous Coronary Intervention on Short- and Long-Term Outcomes: Pooled Analysis From the HORIZONS-AMI and ACUITY Trials. Circ Cardiovasc Interv. 2015 Aug;8(8):e002475. doi: 10.1161/CIRCINTERVENTIONS.114.002475.

    PubMed 26198286

  • Ben-Gal Y, Mohr R, Feit F, Ohman EM, Kirtane A, Xu K, Mehran R, Stone GW. Surgical versus percutaneous coronary revascularization for multivessel disease in diabetic patients with non-ST-segment-elevation acute coronary syndrome: analysis from the Acute Catheterization and Early Intervention Triage Strategy trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002032. doi: 10.1161/CIRCINTERVENTIONS.114.002032.

    PubMed 26019142

  • Genereux P, Bernard S, Palmerini T, Caixeta A, Rosner G, Reiss GR, Xu K, Mehran R, Stone GW; ACUITY Trial Investigators. Incidence, predictors, and impact of neurological events in non-ST-segment elevation acute coronary syndromes: the ACUITY trial. EuroIntervention. 2015 Aug;11(4):399-406. doi: 10.4244/EIJY14M07_06.

    PubMed 25022226

  • Planer D, Mehran R, Ohman EM, White HD, Newman JD, Xu K, Stone GW. Prognosis of patients with non-ST-segment-elevation myocardial infarction and nonobstructive coronary artery disease: propensity-matched analysis from the Acute Catheterization and Urgent Intervention Triage Strategy trial. Circ Cardiovasc Interv. 2014 Jun;7(3):285-93. doi: 10.1161/CIRCINTERVENTIONS.113.000606. Epub 2014 May 20.

    PubMed 24847016

  • Robertson JO, Ebrahimi R, Lansky AJ, Mehran R, Stone GW, Lincoff AM. Impact of cigarette smoking on extent of coronary artery disease and prognosis of patients with non-ST-segment elevation acute coronary syndromes: an analysis from the ACUITY Trial (Acute Catheterization and Urgent Intervention Triage Strategy). JACC Cardiovasc Interv. 2014 Apr;7(4):372-9. doi: 10.1016/j.jcin.2013.11.017. Epub 2014 Mar 14.

    PubMed 24630881

  • Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19.

    PubMed 24561145

  • Madhavan MV, Genereux P, Rubin J, Palmerini T, Caixeta A, Xu K, Weisz G, Mehran R, Stone GW. Usefulness of the SYNTAX score to predict acute kidney injury after percutaneous coronary intervention (from the Acute Catheterization and Urgent Intervention Triage Strategy Trial). Am J Cardiol. 2014 Apr 15;113(8):1331-7. doi: 10.1016/j.amjcard.2013.12.041. Epub 2014 Jan 31.

    PubMed 24560063

  • Meier P, Lansky AJ, Fahy M, Xu K, White HD, Bertrand ME, Mehran R, Stone GW. The impact of the coronary collateral circulation on outcomes in patients with acute coronary syndromes: results from the ACUITY trial. Heart. 2014 Apr;100(8):647-51. doi: 10.1136/heartjnl-2013-304435. Epub 2013 Dec 5.

    PubMed 24310521

  • Ertelt K, Genereux P, Mintz GS, Reiss GR, Kirtane AJ, Madhavan MV, Fahy M, Williams MR, Brener SJ, Mehran R, Stone GW. Impact of the severity of coronary artery calcification on clinical events in patients undergoing coronary artery bypass grafting (from the Acute Catheterization and Urgent Intervention Triage Strategy Trial). Am J Cardiol. 2013 Dec 1;112(11):1730-7. doi: 10.1016/j.amjcard.2013.07.038. Epub 2013 Sep 5.

    PubMed 24012035

  • Palmerini T, Genereux P, Caixeta A, Cristea E, Lansky A, Mehran R, Della Riva D, Fahy M, Xu K, Stone GW. A new score for risk stratification of patients with acute coronary syndromes undergoing percutaneous coronary intervention: the ACUITY-PCI (Acute Catheterization and Urgent Intervention Triage Strategy-Percutaneous Coronary Intervention) risk score. JACC Cardiovasc Interv. 2012 Nov;5(11):1108-16. doi: 10.1016/j.jcin.2012.07.011.

    PubMed 23174634

  • Dangas GD, Claessen BE, Mehran R, Xu K, Fahy M, Parise H, Henriques JP, Ohman EM, White HD, Stone GW. Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes. JACC Cardiovasc Interv. 2012 Nov;5(11):1097-105. doi: 10.1016/j.jcin.2012.07.012.

    PubMed 23174632

  • Ndrepepa G, Neumann FJ, Deliargyris EN, Mehran R, Mehilli J, Ferenc M, Schulz S, Schomig A, Kastrati A, Stone GW. Bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor in patients with non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention after clopidogrel pretreatment: pooled analysis from the ACUITY and ISAR-REACT 4 trials. Circ Cardiovasc Interv. 2012 Oct;5(5):705-12. doi: 10.1161/CIRCINTERVENTIONS.112.972869. Epub 2012 Oct 9.

    PubMed 23048052

  • Rosner GF, Kirtane AJ, Genereux P, Lansky AJ, Cristea E, Gersh BJ, Weisz G, Parise H, Fahy M, Mehran R, Stone GW. Impact of the presence and extent of incomplete angiographic revascularization after percutaneous coronary intervention in acute coronary syndromes: the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Circulation. 2012 May 29;125(21):2613-20. doi: 10.1161/CIRCULATIONAHA.111.069237. Epub 2012 May 1.

    PubMed 22550156

  • Genereux P, Palmerini T, Caixeta A, Rosner G, Green P, Dressler O, Xu K, Parise H, Mehran R, Serruys PW, Stone GW. Quantification and impact of untreated coronary artery disease after percutaneous coronary intervention: the residual SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) score. J Am Coll Cardiol. 2012 Jun 12;59(24):2165-74. doi: 10.1016/j.jacc.2012.03.010. Epub 2012 Apr 4.

    PubMed 22483327

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Angiomax (bivalirudin) anticoagulant in people with Unstable Angina and Myocardial Infarction, run by The Medicines Company 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 8 inclusion and 23 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 Aug 2007. 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?

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00093158, which also lists 36 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 Aug 2007.

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