A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion

Completed · Phase 1

Conditions studied: Arterial Occlusive Diseases

In brief

The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography.

Key facts

Study ID

NCT00418483

Run by

Grifols Therapeutics LLC

People needed

83

Starts

2007-03-01

Expected to finish

2010-04-01

Last updated by the study team

2016-10-31

Who can join

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

You may qualify if…

• Age ≥ 18 years.
• Women of childbearing potential must use adequate contraception for the duration of the study and must have a negative pregnancy test prior to study entry.
• Unilateral limb ischemia: SVS acute ischemia Category I or IIa.
• Onset of symptoms </= 14 days.
• Thrombosed (non-embolic) infrainguinal graft (synthetic, autologous, or single outflow composite) or infrainguinal native artery. For native arteries, only occlusions of ≥ 10 cm in length are eligible.
• Diagnosis of occlusive thrombus in the graft or artery by arteriography after Informed Consent is obtained.
• Ability to traverse the thrombus with a guidewire.
• Signed informed consent prior to study entry.

You may not qualify if…

• Clinical evidence of significant disease that may interfere with the patient successfully completing the trial.
• Women who are pregnant or lactating, or first 10 days post-partum.
• Previous hemorrhagic stroke at any time. Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack (TIA)) within one year.
• Intracranial or spinal neuro-surgery, or severe intracranial trauma in the last 3 months. Major surgery, organ biopsy, or major trauma within the last 10 days. Lumbar puncture or non-compressible arterial puncture in the last 10 days. Intra-ocular surgery within the last 10 days.
• Current bleeding diathesis. Active gastrointestinal or organ bleeding. Minor bleeding such as normal menses, cystitis, or minor hemorrhoidal bleeding are not exclusions.
• Uncontrolled arterial hypertension, defined as a systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg.
• Known intracranial neoplasm, aneurysm, or arterio-venous malformation.
• Platelet count < 75 x 10e9/L.
• Occlusion of a graft within 6 months of placement.
• Medically unable to tolerate an open vascular procedure.
• Known prothrombotic condition.
• Hemoglobin <10.0 g/dL
• Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine > 2.0 mg/dL or subjects on renal dialysis.
• Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days, for example, abciximab (ReoPro®), eptifibatide (Integrilin®) or tirofiban (Aggrastat®).
• Treatment with warfarin (Coumadin®) and with an INR of >1.7 (elevated INR at screening may be corrected prior to study enrollment.)

Where it is running

• Jobst Vascular Institute — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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