Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Phase-II Trial: AdrenoMedullin for Ischemic Stroke Study

What Was Tested

This clinical study looks at Adrenomedullin.

Adrenomedullin (AM), a vasoactive peptide, has strong anti-inflammatory and angiogenic properties, which have been reported to ameliorate the consequences of ischemic stroke in several animal models.

After a phase I study in healthy volunteers, two phase II trials of AM for inflammatory bowel diseases have been recently completed.

Who Took Part

By PubMed's age tags, the people studied were young adults, adults, middle-aged adults, older adults and people over 80, both men and women.

AM or placebo will be administered to patients with non-cardioembolic ischemic stroke within 24 h after stroke onset.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

Because people in this Adrenomedullin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Adrenomedullin.

Some participants received a placebo instead of Adrenomedullin, giving a reference point.

The AMFIS study is an investigator-initiated, randomized, double-blind, phase-II trial.

What Was Measured

The subject headings attached to it are Adrenomedullin, Cardiovascular Agents, Clinical Trials, Phase II as Topic, Ischemic Stroke, Japan and Randomized Controlled Trials as Topic.

Author keywords: Peptide, Protocols and Treatment.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Adrenomedullin.

Its findings take up roughly 4 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2021 (Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association), a journal based in United States.

More context: the Adrenomedullin compound page, all human trials.