Recent Updates
Recently added Catalysts

Cardioplegia

Phase 3

Coronary Artery Bypass Surgery | Small molecule | Cardiovascular |Cardio Diagnostics Holdings Inc.|Last Updated: Oct 21, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment171

FDA Designations

No designations recorded

Clinical trial landscape

Cardioplegia · 1 trial · 2 indications

Phase 3 1
NCT03823521Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™Coronary Artery Bypass Surgery
COMPLETED171 Analytics
PHASE3COMPLETED
Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
Coronary Artery Bypass Surgery
NCT03823521171
Unlock trial analytics

Study Endpoints

Primary Endpoints

Major Deviation in Cardioplexol application
During surgery

Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose).

Secondary Endpoints

TnT Values
During the first 24 hours following myocardial reperfusion
CK-MB Values
During the first 24 hours following myocardial reperfusion
Complete Cardiac Arrest
During Surgery
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Cardioplexol™- Cardioplegia SolutionEXPERIMENTALCardioplexol™ will be used as cardioplegic solution in cardiac surgery

Interventions

NameTypeDescription
Cardioplegia SolutionDRUGCardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Male or female patients between 18 and 80 years of age; * The patient's pre-operative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement; * The operation can be carried out via a ...

Countries:AustriaGermany
Unlock Eligibility Criteria

Frequently asked questions about Cardioplegia

What is Cardioplegia used for?

Cardioplegia is used in coronary artery bypass surgery and valve surgery to stop the heart during the procedure. It is being developed by Cardio Diagnostics Holdings Inc. (CDIO) as a small molecule cardiovascular therapy. The drug is currently in Phase 3 clinical development.

Who makes Cardioplegia?

Cardio Diagnostics Holdings Inc. (CDIO) is developing Cardioplegia. The company is conducting clinical research on the drug for use in coronary artery bypass surgery and valve surgery. Cardioplegia is a small molecule therapy in Phase 3 development.

What phase is Cardioplegia in?

Cardioplegia is in Phase 3 clinical development. It is an investigational drug being studied for coronary artery bypass surgery and valve surgery. The therapy is not yet approved and remains under clinical investigation by Cardio Diagnostics Holdings Inc. (CDIO).

What clinical trials is Cardioplegia in?

Cardioplegia has one completed Phase 3 trial, NCT03823521, titled "Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™". The study enrolled 171 participants in Austria and Germany, including adults aged 18 years and older undergoing coronary artery bypass or valve surgery.

Is Cardioplegia FDA approved?

Cardioplegia is not FDA approved. It is an investigational drug currently in Phase 3 clinical development by Cardio Diagnostics Holdings Inc. (CDIO). The therapy is being studied for use in coronary artery bypass surgery and valve surgery, but has not completed the regulatory approval process.

What is the trial design for Cardioplegia?

The Phase 3 trial for Cardioplegia, NCT03823521, is an observational study with 171 participants. It is not randomized, not double-blind, and has no control group. The study was conducted in Austria and Germany and has been completed.