NCT00116012

Brief 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). 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
Last Updated

November 29, 2006

Status Verified

November 1, 2006

First QC Date

June 26, 2005

Last Update Submit

November 27, 2006

Conditions

Coronary Disease

Keywords

acute coronary syndromerNAPc2unstable anginaNon-STE myocardial infarctionST elevationcardiac enzymesacute coronary syndromesfactor VIIatissue factornematode anticoagulant protein c2anticoagulantsthrombin inhibitorsthrombosis

Outcome Measures

Primary Outcomes (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)

  • 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

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

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

  • Assessment of the ability of rNAPc2 to blunt the release of markers of necrosis

  • Exploration of the relationship between genetic variation and rNAPc2 efficacy

  • +1 more secondary outcomes

Interventions

rNAPc2DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • 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

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Location

Related Publications (1)

  • 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.

    PMID: 17599602DERIVED

Related Links

MeSH Terms

Conditions

Coronary DiseaseAcute Coronary SyndromeAngina, UnstableThrombosis

Interventions

anti-coagulant protein C2, Ancylostoma caninum

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Study Officials

  • Steven Deitcher, MD

    ARCA Biopharma, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

June 1, 2005

Last Updated

November 29, 2006

Record last verified: 2006-11

Locations

US(1)