Progesterone in the Treatment of Acute Hemorrhagic Stroke

Stroke Clinical Trial

Official title:

An International Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Progesterone Combined Intranasal and Intramuscular Administration in Patients With Acute Hemorrhagic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04143880
• Other study ID #: YANWQ001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A large number of preclinical studies have confirmed that progesterone and its metabolites have strong neuroprotective effects. As a neuroprotective agent, progesterone has been effective in several animal models of nerve injury, suggesting that the drug has a wide range of neuroprotective effects. Pharmacodynamic studies have shown that some characteristic mechanisms of the action of the neurosteroid on brain injury and cerebral congestion include: prevention of inflammatory reaction and cell death (by inhibiting the activation of inflammatory cytokines and microglia); control of angiogenic brain edema (by reestablishing blood-brain barrier and regulating aquaporin-4 water transporter) and cytotoxic edema (by regulating Progesterone can also improve the neural dysfunction after cerebral hemorrhage, promote the regeneration and repair of damaged axons (activate PI3K / Akt pathway to inhibit the expression of RhoA), prevent the loss of Ca2 + caused by excitotoxicity and improve the survival rate of neurons. It was found that progesterone injection could reduce brain edema and promote the recovery of nerve function after brain injury.

Description:

The purpose of this clinical trial is to further evaluate the safety and effectiveness of progesterone in the clinical application of major cerebral congestion diseases. The Second Affiliated Hospital of Zhejiang University is the unit in charge of clinical research, and six units participate in the multicenter randomized, double-blind, placebo-controlled clinical trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Acute hemorrhagic stroke was confirmed by CT or MRI. There should be no obvious sequelae symptoms in the first stroke or previous stroke, Mrs < 2 (slight or no neurological dysfunction).

• Patients aged 40-80 (male, menopausal women);

• Patients with 6-48 hours of onset;

• 3 points = NIHSS score = 15 points for light and medium patients;

• Patients or family members sign informed consent.

Exclusion Criteria:

• Cerebral CT has excluded intracranial hemorrhage, and there is no imaging change of early large area cerebral infarction.

• Pregnant or lactating women;

• Previous intracranial hemorrhage, including suspected subarachnoid hemorrhage; large area stroke (> 2 / 3 MCA territory) or head CT showed any degree of midline displacement due to brain edema. Signs of intracranial hemorrhage (ICH, SAH, extradural hemorrhage, acute or chronic SDH) were found on baseline CT or MRI scan.

• Fever, defined as central body temperature > 37.5 ?;

• Patients with severe heart, liver and kidney dysfunction or severe diabetes;

• Platelet count was less than 100 × 109 / L, blood glucose was less than 27 mmol / L, serum creatinine was more than 2.0 mg / dL or 180 µ mol / L.

• Blood pressure: systolic pressure > 180 mmHg, or diastolic pressure > 100 mmHg;

• Those who have previous allergic history to progesterone and citicoline;

• The anticoagulant has been taken orally, and INR is more than 15; heparin has been taken within 48 hours (APTT is beyond the normal range);

• Participating in clinical trials of any other treatment;

• Patients considered by the researchers not suitable for inclusion.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Progesterone
intramuscular injection intranasal administration

Other:
• saline
intramuscular injection intranasal administration

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Huzhou Central Hospital, Jinhua Central Hospital, Korea University Anam Hospital, Lishui Country People's Hospital, Seoul National University Hospital, The Affiliated Hospital of Hangzhou Normal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale	The percentage of patients with Mrs score 0, 1 and 2 was compared.	3 month