NCT00111852

Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00111852

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Prospective, Randomized, Double-blind, Placebo-controlled, Single Bolus, Multinational, Multi-center, Parallel Group, Dose-ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke

Summary

The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.

Eligibility

Inclusion Criteria:

* Eligible for study treatment within 3-9 hours after onset of stroke symptoms.
* Score of 4-24 on the NIHSS with clinical signs of hemispheric infarction (i.e. hemiparesis) suggestive of ischemic stroke.

Inclusion Criteria from diagnostic imaging screening:

* Distinct penumbra (at least 20%), measured by MRI (PWI/DWI) or perfusion CT, related to middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory in a hemispheric distribution.

Exclusion Criteria:

* History or clinical presentation of intracranial hemorrhage (ICH), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, or cerebral neoplasm.
* Rapidly improving neurological symptoms.
* Pre-stroke MRS score of \> 1 (including previous disability).
* Suspected acute vertebral or basilar artery occlusion.
* Current use of anticoagulants and a prolonged prothrombin time.
* Uncontrolled hypertension.
* Baseline hematocrit of \< 0.25.
* Baseline platelet count \< 100,000/mm3.

Disease(s) and\or Condition(s)

Stroke, Acute

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Desmoteplase
- Description: Desmoteplase 90 mcg/kg, intravenous administration.
- Arm Group Labels: Desmoteplase, low dose
- Type: DRUG
- Name: Desmoteplase
- Description: Desmoteplase 125 mcg/kg, intravenous administration.
- Arm Group Labels: Desmoteplase, high dose
- Type: DRUG
- Name: Placebo
- Description: Dose-Match Placebo, intravenous administration.
- Arm Group Labels: Placebo

Sponsor

Forest Laboratories