A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion

Phase 2

Completed

Conditions: Acute Peripheral Arterial Occlusion

Registration Number: NCT01222117

Lead Sponsor: Grifols Therapeutics LLC

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 174

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 <75 x 10e9/L
Active graft infection
Occlusion occurred within one month of synthetic graft placement
Occlusion occurred within 6 months of autologous graft placement
A sequential composite graft with dual outflows to correct multiple occlusions
Medically unable to tolerate an open vascular procedure
Known prothrombotic state
Hemoglobin <10.0 g/dL
Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine >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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects With >50% Thrombolysis	5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)	The proportion of subjects with \>50% thrombolysis at the end of treatment compared to baseline by arteriography.

Secondary Outcome Measures

Name	Time	Method
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.	30 days	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.

Trial Locations

Locations (39): Kaleida Health System
🇺🇸
Buffalo, New York, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Ziekenhuis Oost Limburg, Campus St. Jan
🇧🇪
Genk, Limburg, Belgium
Erasme Hospital, Brussels
🇧🇪
Brussels, Belgium
University Hospital Antwerp
🇧🇪
Edegem, Belgium
Chirurgie UZ Leuven
🇧🇪
Leuven, Belgium
Clinic of Vascular Surgery and Angiology
🇧🇬
Sofia, Bulgaria
Tokuda Hospital Sofia
🇧🇬
Sofia, Bulgaria
Vascular Centre Vitkovicka Nemocnice
🇨🇿
Ostrava - Vitkovice, Czech Republic
Cevni Chirurgie, Nemocnice Na Homolce
🇨🇿
Prague, Czech Republic
Scroll for more (29 remaining)
Kaleida Health System
🇺🇸Buffalo, New York, United States