Study of ARC1779 in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI) (vITAL-1)
| ISRCTN | ISRCTN01837376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01837376 |
| ClinicalTrials.gov number | NCT00507338 |
| Secondary identifying numbers | ARC1779-003 |
- Submission date
- 10/01/2008
- Registration date
- 28/02/2008
- Last edited
- 08/08/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Gibson
Scientific
Scientific
350 Longwood Avenue
Boston
02115
United States of America
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A phase 2 study of an aptameric von Willebrand Factor antagonist, ARC1779, in patients with acute myocardial infarction undergoing percutaneous coronary intervention |
| Study acronym | vITAL-1 |
| Study objectives | 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(s) | Ethics Committee of the Medical University of Vienna and the General Hospital of the City of Vienna. Date of approval: 27 November 2007 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | aptameric von Willebrand Factor antagonist (ARC1779) |
| Primary outcome measure | Adequacy of reperfusion (Time frame: 48 hours post-PCI) |
| Secondary outcome measures | Bleeding (Time frame: PCI to hospital discharge) |
| Overall study start date | 01/10/2007 |
| Completion date | 31/10/2008 |
| Reason abandoned (if study stopped) | Trial terminated due to the mode of administration of drug being unfeasible for this proposed indication. Please keep reason for termination confidential. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 31/10/2008 |
Locations
Countries of recruitment
- Austria
- Canada
- Germany
- Israel
- Poland
- Russian Federation
- United States of America
Study participating centre
350 Longwood Avenue
Boston
02115
United States of America
02115
United States of America
Sponsor information
Archemix Corp (USA)
Industry
Industry
300 3rd Street
Cambridge
02142
United States of America
| Phone | +1 617 621 7700 |
|---|---|
| jgilbert@archemix.com | |
"ROR" |
https://ror.org/00v8tzb98 |
Funders
Funder type
Industry
Archemix Corp (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
