Phase 2
N=174
A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion
Acute Peripheral Arterial Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01222117 ↗Enrolled (actual)
174
Serious AEs
27.8%
Results posted
May 2016
Primary outcome: Primary: The Proportion of Subjects With >50% Thrombolysis — 43.8; 47.4; 81.0; 47.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plasmin (Biological); Plasminogen Activator (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grifols Therapeutics LLC
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects With >50% Thrombolysis |
43.8; 47.4; 81.0; 47.4; 88.9; 40.0 | — |
| SECONDARY The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability. |
80.0; 60.0; 81.8; 70.0; 77.8; 88.9 | — |
Summary
The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250 mg doses.
Eligibility Criteria
Inclusion Criteria
- Unilateral limb ischemia - Society of Vascular Surgery Categories I and IIa
- Onset of symptoms less than or equal to 14 days
- Thrombosed infrainguinal bypass graft or native artery
- Diagnosis by arteriography of occlusive thrombus in graft or artery
- Ability to embed the infusion catheter into the thrombus
- Women of childbearing potential must use contraception and have a negative pregnancy test
Exclusion Criteria
- Any medical or social condition that may interfere with study participation
- Women who are pregnant or lactating
- Hemorrhagic stroke history
- Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack) within one year
- Intracranial or spinal neurosurgery, or severe intracranial trauma in the last 3 months
- Major surgery, organ biopsy, or major trauma within the past 10 days
- Lumbar puncture or non-compressible arterial puncture in the past 10 days
- Intraocular surgery within the past 10 days
- Active gastrointestinal or organ bleeding
- Uncontrolled arterial hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
- Known intracranial neoplasm, aneurysm, or arteriovenous malformation
- Current bleeding diathesis
- Platelet count 2.0 mg/dL
- Treatment with a full dose plasminogen activator (PA) within the last 48 hours
- Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days
- Treatment with oral anticoagulants, and with an international normalized ratio of >1.7
Data sourced from ClinicalTrials.gov (NCT01222117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.