AzTrials
AzTrials

Coronary DiseasePhase 2NCT00116012

Anticoagulation With rNAPc2 to Eliminate MACE/TIMI 32

A Phase 2 study testing rNAPc2 in people with Coronary Disease, run by ARCA Biopharma, Inc. 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
Search all trials

Trial summary

The primary focus of this study is to explore the safety of a range of doses of rNAPc2 in subjects who are managed in hospitals that most typically practice an early invasive strategy (catheterization during the index admission). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Disease
What is being tested?
rNAPc2
How many people
300 participants
Where
1 siteUnited States
Study dates
Jun 2005to not given
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 18 to 75 years inclusive
  • Ischemic symptoms lasting >= 5 minutes at rest within the prior 48 hours
  • Able to be randomized within 48 hours of recent ischemic events
  • At least one of the following criteria (A, B, or C): A. Elevation of CK-MB or troponin above upper limit of normal OR B. ST segment deviation (depression or transient elevation) of at least 0.5 mm OR C. TIMI risk score >= 3, defined as three or more of the following:
  • Age >= 65;
  • At least 3 of the following risk factors: hypertension, diabetes mellitus, current smoker (within 1 year), dyslipidemia, family history of premature coronary artery disease (< age 60);
Show all 13Show fewer
  • Known or prior coronary artery stenosis > 50%;
  • Daily aspirin use for at least 7 days;
  • >= 2 ischemic episodes at rest lasting >= 15 minutes each within the prior 24 hours;
  • Elevation of CK-MB OR troponin above upper limit of normal;
  • ST segment deviation (depression or transient elevation) of at least 0.5 mm.
  • Ability to understand and willingness to give written informed consent
  • Planned early invasive strategy in the index hospitalization

Who cannot join

  • Index event is ST-segment elevation MI or new LBBB
  • CABG is planned within 7 days
  • ACS is secondary to non-atherosclerotic mechanism (e.g. thyrotoxicosis, anemia)
  • Prior participation in ANTHEM-TIMI 32, prior exposure to rNAPc2, or participation in a study with any experimental drug or device within 30 days
  • Pregnancy, lactation or use of an intrauterine device (note: women of childbearing potential must have a negative b-HCG)
  • Active renal disease, Cr > 4 mg/dl, or history of renal transplantation
Show all 20Show fewer
  • History of a bleeding diathesis or recurrent bleeding episodes
  • Medical comorbidities which place subject at risk for hemorrhage, including, but not limited to, prior cerebral hemorrhage, arteriovenous malformation, non-hemorrhagic CVA or TIA, GI bleed, active PUD, advanced liver or renal disease. Major trauma, surgery, CNS, spinal or eye surgery within 6 months, or parenchymal organ biopsy within 14 days.
  • Uncontrolled hypertension (SBP > 180, DBP > 100) despite 1 hour of adequate treatment
  • Gross hematuria within 1 month unless catheterized and subsequently resolved
  • Chronic warfarin (INR > 1.4) or anticipated therapy for warfarin
  • Platelet count < 120,000/mm3 at randomization or history of thrombocytopenia (confirm in a blue-top tube using sodium citrate)
  • Significant anemia (M: Hg < 11 g/dL, F: Hg < 10 g/dL) at randomization
  • Active liver disease or ALT and AST > 3 x ULN not felt to be part of presenting ACS
  • Fibrinolytic agent within 24 hours or planned use of fibrinolytics
  • Known allergy or intolerance to aspirin
  • Known allergy to heparin, enoxaparin or pork-based products
  • History of heparin-induced thrombocytopenia (type 1 or 2)
  • Any condition for which the investigator feels enrollment in the study would place the subject at unacceptable risk (e.g. substance abuse)
  • Part 2 ONLY: Use of LMWH or Xa inhibitor (e.g. Angiomax, Argatroban) >= 12 hours before randomization

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts

Other trials in United States

About this study

Official title: A Randomized, Double-Blind Placebo-Controlled Study to Assess the Safety of Factor VIIa/Tissue Factor Inhibitor, Recombinant Nematode Anticoagulant Protein c2 (rNAPc2), in Subjects With Non-ST-Elevation Acute Coronary Syndromes - ANTHEM (Anticoagulation With rNAPc2 to Help Eliminate MACE)/TIMI 32. Amendment #3 - A Single Arm, Open-Label Study of rNAPc2 With Reduced Doses of Unfractionated Heparin

The primary focus of this study is to explore the safety of a range of doses of rNAPc2 in subjects who are managed in hospitals that most typically practice an early invasive strategy (catheterization during the index admission). After completion of the ascending dose-ranging part of the trial and review of these data by the Data and Safety Monitoring Board (DSMB), the maximum tolerated dose of rNAPc2 will be studied in single-arm, open-label panels (approximately 25 subjects each) of rNAPc2 with descending doses of unfractionated heparin (UFH).

Read the detailed description

Acute coronary syndromes (ACS), which include unstable angina and non-ST-elevation (non-STE) myocardial infarction, represent a serious clinical condition affecting over 1,000,000 people in the US alone. The combined rate of death and myocardial infarction (MI) in ACS patients is 8-15% after one month, in spite of the best current therapy including use of low-molecular weight heparins, glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors, and an early invasive strategy. Given the high prevalence of the disorder, further improvements in the outcomes in these patients are very desirable.

It is currently believed that the principle cause of the clinical symptoms characterizing ACS results from the transient thrombotic occlusion of one or more coronary vessels. Coronary thrombosis is initiated by the exposure of the protein tissue factor (TF), which can be found in the sub-endothelial layer of the blood vessel and is a major component of atherosclerotic gruel. The exposure of TF following vascular damage or rupture of a coronary atherosclerotic plaque, results in the rapid formation of the enzymatic complex composed of TF and the serine protease factor VIIa (fVIIa/TF). The fVIIa/TF complex initiates an amplified cascade of proteolytic activation steps resulting in the formation of the serine protease thrombin. The highly amplified generation of thrombin localized to the site of vascular damage or plaque rupture, coupled with the high-shear rheological environment of the coronary vessel, results in the activation and subsequent aggregation of platelets and the formation of an insoluble matrix of fibrin resulting in a platelet-rich thrombus.

The critical role of the fVIIa/TF complex in the initiation of coronary thrombosis suggests that it may be an ideal target for inhibitors that will result in an attenuation of thrombin generation and subsequent thrombus formation. Recombinant nematode anticoagulant protein c2 (rNAPc2) is a novel and potent inhibitor of fVIIa/TF that may improve current therapeutic strategies in reducing the extent of coronary thrombosis and subsequent clinical events in patients diagnosed with ACS.

Being tested
rNAPc2
Keywords
acute coronary syndrome, rNAPc2, unstable angina, Non-STE myocardial infarction, ST elevation, cardiac enzymes, acute coronary syndromes, factor VIIa, tissue factor, nematode anticoagulant protein c2, anticoagulants, thrombin inhibitors, thrombosis
Medical subject headings
Coronary Disease, Acute Coronary Syndrome, Angina, Unstable, Thrombosis

What participants receive

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

  • rNAPc2Drug

What is being measured

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

  1. Evaluation of the effects of a range of doses of rNAPc2 in subjects with non-STE acute coronary syndrome on safety and laboratory parameters from randomization until 7 days after the last dose of study drug

Secondary outcomes (6)

  1. Evaluation of the effects of a range of doses of rNAPc2 on the presence of ischemia following randomization as identified via continuous ST segment (Holter) monitoring

  2. Evaluation of the effects of a range of doses of rNAPc2 on pharmacodynamic and pharmacokinetic measures

  3. Evaluation of the effects of rNAPc2 on major cardiovascular clinical events over the period from randomization until six months following randomization

  4. Assessment of the ability of rNAPc2 to blunt the release of markers of necrosis

  5. Exploration of the relationship between genetic variation and rNAPc2 efficacy

  6. Evaluation of the efficacy and safety of rNAPc2 with reduced-dose (including no) unfractionated heparin (UFH)

Timeline

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

  1. First posted27 Jun 2005 (estimated)
  2. Study startJun 2005

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
Single group
Masking
None (open label)
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00116012
Sponsor's protocol ID
NUVO-0201
Other IDs
ANTHEM
Status last verified
Nov 2006
First submitted
26 Jun 2005
Last updated
29 Nov 2006
Results posted
No

Publications

  • Giugliano RP, Wiviott SD, Stone PH, Simon DI, Schweiger MJ, Bouchard A, Leesar MA, Goulder MA, Deitcher SR, McCabe CH, Braunwald E; ANTHEM-TIMI-32 Investigators. Recombinant nematode anticoagulant protein c2 in patients with non-ST-segment elevation acute coronary syndrome: the ANTHEM-TIMI-32 trial. J Am Coll Cardiol. 2007 Jun 26;49(25):2398-407. doi: 10.1016/j.jacc.2007.02.065. Epub 2007 Jun 11.

    PubMed 17599602

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rNAPc2 in people with Coronary Disease, run by ARCA Biopharma, Inc. 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 13 inclusion and 20 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 29 Nov 2006. 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 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?

Evaluation of the effects of a range of doses of rNAPc2 in subjects with non-STE acute coronary syndrome on safety and laboratory parameters from randomization until 7 days after the last dose of study drug. 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 NCT00116012, which also lists 1 linked publication.

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 29 Nov 2006.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in