Condition category
Circulatory System
Date applied
10/01/2008
Date assigned
28/02/2008
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Gibson

ORCID ID

Contact details

350 Longwood Avenue
Boston
02115
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00507338

Protocol/serial number

ARC1779-003

Study information

Scientific title

A phase 2 study of an aptameric von Willebrand Factor antagonist, ARC1779, in patients with acute myocardial infarction undergoing percutaneous coronary intervention

Acronym

vITAL-1

Study hypothesis

Adjunctive anti-thrombotic therapy for PCI of Acute Myocardial Infarction (AMI) may be improved by incorporation of a novel anti-platelet therapeutic principle, von Willebrand Factor antagonism. ARC1779 is a therapeutic oligonucleotide ("aptamer") which blocks the binding of the A1 domain of vWF to the platelet GP1b receptor, and thereby modulates platelet adhesion, activation, and aggregation under the high shear conditions of coronary arterial stenosis and plaque rupture. This study is intended to provide dose-ranging and clinical proof of concept for ARC1779 in a primary PCI population.

Ethics approval

Ethics Committee of the Medical University of Vienna and the General Hospital of the City of Vienna. Date of approval: 27 November 2007

Study design

Randomized, double-blind (subject, caregiver, investigator, outcomes assessor), active control, parallel assignment, multi-center, safety/efficacy study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute myocardial infarction

Intervention

Please note that as of 14/05/2008 this trial was terminated.

Procedure: Primary PCI
Study Drugs: Active control - Abciximab (ReoPro®) labeled regimen for primary PCI. Investigational agent - ARC1779 Injection 0.1 mg/kg, 0.3 mg/kg, or 1.0 mg
Duration: Bolus + 12 hr infusion
Frequency: 1 x treatment
Mode of Administration: Intravenous

Intervention type

Drug

Phase

Not Specified

Drug names

aptameric von Willebrand Factor antagonist (ARC1779)

Primary outcome measures

Adequacy of reperfusion (Time frame: 48 hours post-PCI)

Secondary outcome measures

Bleeding (Time frame: PCI to hospital discharge)

Overall trial start date

01/10/2007

Overall trial end date

31/10/2008

Reason abandoned

Trial terminated due to the mode of administration of drug being unfeasible for this proposed indication. Please keep reason for termination confidential.

Eligibility

Participant inclusion criteria

1. Troponin-positive Non-ST-segment Elevation Myocardial Infarction (NSTEMI), with diagnostic symptoms and/or electrocardiogram (ECG) abnormalities present within the preceding 24 hours, and a planned "early invasive" management strategy
2. ST-Segment Elevation Myocardial Infarction (STEMI), with planned primary PCI

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
2. Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours
3. Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours
4. Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled on antihypertensive therapy
5. Major surgery or trauma within the preceding 6 weeks
6. History of stroke within 30 days or any history of hemorrhagic stroke
7. End-Stage Renal Disease (ESRD) with dependency on renal dialysis

Recruitment start date

01/10/2007

Recruitment end date

31/10/2008

Locations

Countries of recruitment

Austria, Canada, Germany, Israel, Poland, Russian Federation, United States of America

Trial participating centre

350 Longwood Avenue
Boston
02115
United States of America

Sponsor information

Organisation

Archemix Corp (USA)

Sponsor details

300 3rd Street
Cambridge
02142
United States of America
+1 617 621 7700
jgilbert@archemix.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Archemix Corp (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes