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Conventional medical treatment

Phase 2

Coronary Atherosclerosis and Other Heart Disease | Small molecule | Cardiovascular |Design Therapeutics, Inc.|Last Updated: Nov 8, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02022514Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.PHASE2 COMPLETED 28 — — Nov 1, 2013Aug 1, 2023Nov 8, 20232 Spain
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Study Endpoints
Primary Endpoints
The primary endpoint will be the change in ejection fraction measured by magnetic resonance between inclusion and at 6 months follow-up
6 months
Secondary Endpoints
Changes of NYHA functional grade comparative manner between the groups.
6 months
Possible cardiac events during follow-up (death, myocardial infarction, repeat revascularization).
6 months
Need for hospital admission or presence of major arrhythmia
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mononuclear cells from autologous bone marrowEXPERIMENTALMononuclear bone marrow cells autologous intracoronary
Conventional medical treatmentACTIVE_COMPARATORConventional medical treatment
Interventions
NameTypeDescription
Mononuclear cells from autologous bone marrowOTHERMononuclear bone marrow cells autologous intracoronary
Conventional medical treatmentDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Patients who give their informed consent to participate in this clinical trial. 2. Patients of both sexes with atherosclerotic coronary artery disease and chronic occlusions that recanalization has been achieved successfully implanted medicated stents, and in which neverthele...

Countries:Spain
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