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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Peripheral Arterial Occlusion

In brief

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.

Key facts

Study ID

NCT01222117

Run by

Grifols Therapeutics LLC

People needed

174

Starts

2010-12-01

Expected to finish

2016-01-01

Last updated by the study team

2017-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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, Czechia
• Cevni Chirurgie, Nemocnice Na Homolce — Prague, Czechia
• IKEM, Kardiologicka klinika — Prague, Czechia
• University Hospital Kralovske Vinobrady — Prague, Czechia
• Chirurgicka klinika IPVZ — Ústí nad Labem, Czechia
• Universitätsklinikum Bonn, Radiologische Universitätsklinik — Bonn, Germany
• Universitäts GefäßCentrum Uniklinikum Dresden — Dresden, Germany
• Klinik für Innere Medizin I - Angiologie / Kardiologie — Leipzig, Germany
• Life Care Institute of Medical Sciences and Research — Gujarat, India
• Gokula Metropolis Clinical Research Centre, M. S. Ramaiah Hospital — Karnataka, India
• Centro de Investigación y Atención Cardiovascular — Lima, Peru
• Hospital Nacional Edgardo Rebagliati Martins — Lima, Peru
• Hospital Nacional Guillermo Almenara Irigoyen-EsSalud — Lima, Peru
• Instituto Neuro Cardiovascular de las Americas — Lima, Peru
• Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu — Bytom, Poland
• Malopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland Sp. z o.o — Chrzanów, Poland
• Uniwersyleckie Centrum Kliniczne — Gdansk, Poland

Full record on ClinicalTrials.gov

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