Acute Myocardial InfarctionPhase 2vITAL-1NCT00507338
Study of ARC1779 in Patients With Acute Myocardial Infarction Undergoing PCI
A Phase 2 study testing PCI in people with Acute Myocardial Infarction, run by Archemix Corp. at 1 site in Russia.
Trial summary
ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2007to Feb 2008
- 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
- troponin-positive NSTEMI, with diagnostic symptoms and/or ECG abnormalities present within the preceding 24 hours, and a planned "early invasive" management strategy
- STEMI, with planned primary PCI
Who cannot join
- History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
- Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours
- Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours
- Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled on antihypertensive therapy
- Major surgery or trauma within the preceding 6 weeks
- History of stroke within 30 days or any history of hemorrhagic stroke
- End-stage renal disease (ESRD) with dependency on renal dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack.
Read the detailed description
Adjunctive anti-thrombotic therapy for PCI of 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 GPIb 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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- PCI
- Keywords
- percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
early PCI for NSTEMI; primary PCI for STEMI
| Study group | Role | What they receive |
|---|---|---|
| ARC1779 low dose | Experimental | 0.1 mg/kg Receives: Procedure: PCI |
| ARC1779 mid dose | Experimental | 0.3 mg/kg Receives: Procedure: PCI |
| ARC1779 high dose | Experimental | 1.0 mg/kg Receives: Procedure: PCI |
| abciximab | Active comparator | labeled regimen for primary PCI Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequacy of reperfusion
Measured: 48 hours post-PCI
Secondary outcomes (1)
bleeding
Measured: PCI to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Archemix Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Gibson, MD, Study chair, Harvard Medical School, Beth Israel Deaconess Medical CenterFranz-Josef Neumann, MD, Principal investigator, Herz-Zentrum Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507338
- Sponsor's protocol ID
- ARC1779-003
- Acronym
- vITAL-1
- Status last verified
- Jan 2009
- First submitted
- 24 Jul 2007
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PubMed 30957581
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of an Aptameric Von Willebrand Factor Antagonist, ARC1779, in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00507338
- Acronym / sponsor ID
- vITAL-1 / ARC1779-003
- Conditions
- Acute Myocardial Infarction
- Keywords
- percutaneous coronary intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Archemix Corp.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 26 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ARC1779 is a novel drug being tested in patients undergoing angioplasty and stenting as their primary treatment for heart attack.
Detailed description
Adjunctive anti-thrombotic therapy for PCI of 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 GPIb 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARC1779 low dose | Experimental | Procedure: PCI0.1 mg/kg |
| ARC1779 mid dose | Experimental | Procedure: PCI0.3 mg/kg |
| ARC1779 high dose | Experimental | Procedure: PCI1.0 mg/kg |
| abciximab | Active comparator | Procedure: PCIlabeled regimen for primary PCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- troponin-positive NSTEMI, with diagnostic symptoms and/or ECG abnormalities present within the preceding 24 hours, and a planned "early invasive" management strategy
- STEMI, with planned primary PCI
Key exclusion criteria (7 listed)
- History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
- Received treatment with fibrinolytic or GPIIb/IIIa antagonist drugs within the preceding 72 hours
- Received anticoagulant therapy with a low molecular weight heparin within the preceding 8 hours
- Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled on antihypertensive therapy
- Major surgery or trauma within the preceding 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIearly PCI for NSTEMI; primary PCI for STEMI | Procedure or surgery | ARC1779 high dose, ARC1779 low dose, ARC1779 mid dose, abciximab |
Primary outcome
adequacy of reperfusion
Time frame: 48 hours post-PCI
1 secondary outcome
bleeding
Time frame: PCI to hospital discharge
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
- Derived from this study: PubMed 30957581Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gibson, MD study chair
Harvard Medical School, Beth Israel Deaconess Medical Center
Franz-Josef Neumann, MD principal investigator
Herz-Zentrum Bad Krozingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCI in people with Acute Myocardial Infarction, run by Archemix Corp. at 1 site in Russia.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 9 Jan 2009. 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 Russia. 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 was stopped early. Results are not available in the source record.
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?
adequacy of reperfusion (time frame: 48 hours post-PCI). 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 NCT00507338, 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 9 Jan 2009.