Arterial Occlusive DiseasesPhase 3NCT00115999
Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries
A Phase 3 study testing alfimeprase in people with Arterial Occlusive Diseases, run by ARCA Biopharma, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- alfimeprase
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Feb 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must give written informed consent
- Ages 18 or older
- Acute PAO of a lower extremity with onset of symptoms within 14 days prior to randomization
- Acute index limb ischemia classified as SVS/ISCVS Class I or IIA caused by occlusion of a native artery and/or bypass graft (vein or prosthetic)
- Need for open vascular surgical intervention in the event of unsuccessful thrombolysis
- Available for follow-up assessments
Who cannot join
- Contraindication to systemic anticoagulation
- History of endovascular procedure or open vascular surgery on the index limb within the last 30 days
- History of significant acute or chronic kidney disease that would preclude contrast angiography
- Known allergy to contrast agents
- History of heparin-induced thrombocytopenia (HIT)
- Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
Show all 16Show fewer
- Any thrombolytic therapy within 30 days prior to randomization
- Past participation in any alfimeprase clinical trial
- History of hypersensitivity to aspirin
- Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
- Uncontrolled hypertension: systolic blood pressure (BP) > 180 mmHg, or diastolic BP > 110 mmHg at the time of baseline assessment
- Hematocrit < 30%; subjects with a low hematocrit who are not actively bleeding can be entered into this study if after transfusion their hematocrit is >= 30%
- Platelet count <100 X 10(9)/L on baseline labs
- Investigator inability to advance guidewire through index occlusion
- Medically unable to withstand an open vascular surgical procedure
- Any other feature that, in the opinion of the investigator, should preclude study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3, Multicenter, Multi-National, Randomized, Partial Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Acute Peripheral Arterial Occlusion
The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.
Read the detailed description
There is an unmet medical need to improve thrombolytic therapy in acute peripheral arterial occlusion (PAO). Currently used plasminogen activators can result in increased circulating levels of plasmin that result in a systemic "lytic state" that does not distinguish between physiologic and pathologic thrombosis. In general, mean plasminogen activator infusion durations of greater than 24 hours in order to achieve successful thrombolysis are problematic in a disease where delayed restoration of arterial flow can lead to irreversible ischemic damage. A direct thrombolytic agent like alfimeprase, with a rapid mechanism of action and a potentially safer bleeding risk profile, could facilitate a rapid restoration of arterial flow and avoidance of open vascular surgery.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- alfimeprase
- Keywords
- PAO, acute peripheral arterial occlusion, thrombolysis, blood clot, leg attack, alfimeprase, thrombus, embolism, thromboembolism, claudication, thrombolytic, thrombosis, plasminogen activator, arterial flow
- Medical subject headings
- Arterial Occlusive Diseases, Thrombosis, Embolism, Thromboembolism, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfimepraseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day open vascular surgery free rate
Secondary outcomes (8)
Rate of arterial flow restoration at 4 hours after initiation of study drug
Rate of improvement in index limb ABI by >=0.15 at 30 days
Change in the severity of planned surgical procedures at 30 days
Change in index limb pain severity score at 30 days
30 day open vascular surgery free survival rate
Length of hospital stay
Length of intensive care unit (ICU) stay
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startApr 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- ARCA Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven R Deitcher, MD, Study director, ARCA Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115999
- Sponsor's protocol ID
- HA004
- Other IDs
- NAPA-2
- Status last verified
- Jan 2008
- First submitted
- 26 Jun 2005
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Multi-National, Randomized, Partial Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Acute Peripheral Arterial Occlusion
- ClinicalTrials.gov ID
- NCT00115999
- Acronym / sponsor ID
- HA004
- Conditions
- Arterial Occlusive Diseases
- Keywords
- PAO, acute peripheral arterial occlusion, thrombolysis, blood clot, leg attack, alfimeprase, thrombus, embolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- ARCA Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 27 Jun 2005 (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.
The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.
Detailed description
There is an unmet medical need to improve thrombolytic therapy in acute peripheral arterial occlusion (PAO). Currently used plasminogen activators can result in increased circulating levels of plasmin that result in a systemic "lytic state" that does not distinguish between physiologic and pathologic thrombosis. In general, mean plasminogen activator infusion durations of greater than 24 hours in order to achieve successful thrombolysis are problematic in a disease where delayed restoration of arterial flow can lead to irreversible ischemic damage. A direct thrombolytic agent like alfimeprase, with a rapid mechanism of action and a potentially safer bleeding risk profile, could facilitate a rapid restoration of arterial flow and avoidance of open vascular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must give written informed consent
- Ages 18 or older
- Acute PAO of a lower extremity with onset of symptoms within 14 days prior to randomization
- Acute index limb ischemia classified as SVS/ISCVS Class I or IIA caused by occlusion of a native artery and/or bypass graft (vein or prosthetic)
- Need for open vascular surgical intervention in the event of unsuccessful thrombolysis
Key exclusion criteria (16 listed)
- Contraindication to systemic anticoagulation
- History of endovascular procedure or open vascular surgery on the index limb within the last 30 days
- History of significant acute or chronic kidney disease that would preclude contrast angiography
- Known allergy to contrast agents
- History of heparin-induced thrombocytopenia (HIT)
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 |
|---|---|---|
| alfimeprase | Drug | – |
Primary outcome
30 day open vascular surgery free rate
8 secondary outcomes
Rate of arterial flow restoration at 4 hours after initiation of study drug
Rate of improvement in index limb ABI by >=0.15 at 30 days
Change in the severity of planned surgical procedures at 30 days
Change in index limb pain severity score at 30 days
30 day open vascular surgery free survival rate
Length of hospital stay
Length of intensive care unit (ICU) stay
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
- Company websiteLink provided by the sponsor.
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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.
Steven R Deitcher, MD study director
ARCA Biopharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alfimeprase in people with Arterial Occlusive Diseases, 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 6 inclusion and 16 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 15 Jan 2008. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
30 day open vascular surgery free rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2008.