Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175058
Status:
COMPLETED
Last Update Posted:
2012-06-18
First Post:
2005-09-09
Brief Title:
Acute Myocardial Infarction With HyperOxemic Therapy II AMIHOT II
Sponsor:
TherOx
Organization:
TherOx
Study Overview
Official Title:
Acute Myocardial Infarction With HyperOxemic Therapy II
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMIHOT II
Brief Summary:
To determine whether or not HyperOxemic therapy rendered to patients that meet the study inclusion criteria with anterior acute myocardial infarction 6 hours from symptom onset to reperfusion results in a significant reduction in infarct size as measured by SPECT 14 days post event
Detailed Description:
The AMIHOT II clinical trial is designed as a focused study of a promising patient subset from the completed AMIHOT study A brief synopsis of the AMIHOT experience is provided below followed by a description of the AMIHOT II study
The pivotal AMIHOT clinical study for the TherOx Aqueous Oxygen AO System in treating post acute myocardial infarction AMI patients was approved by FDA on January 10 2002 under IDE G980257S011 The study objective was to determine whether the adjunctive administration of AO Therapy immediately after successful PCI in a group of patients presenting less than 24 hours from AMI symptom onset improves left ventricular function and reduces the area of infarction with no increased incidence of 30-day Major Adverse Cardiac Events MACE when compared to a control group receiving only PCI standard-of-care treatment 30-day MACE comprises the combined incidence of death reinfarction target vessel revascularization and stroke
Two hundred eighty-nine 289 patients were enrolled from January 16 2002 through December 24 2003 including 20 run-in subjects and 269 randomized patients Three independent biomarkers infarct size reduction regional wall motion score improvement at three months and reduction in ST segment elevation were designated as co-primary endpoints to evaluate the effectiveness of AO Therapy The study was designed to demonstrate superiority of the AO Therapy group as compared to controls for each of these endpoints and to demonstrate non-inferiority of the AO Therapy group as compared to Control with respect to 30-day MACE The study population was comprised of qualifying AMI patients treated with either PCI alone or with AO Therapy as an adjunct to successful PCI within 24 hours of symptom onset
The observed 30-day MACE rates were comparable between the AO Therapy and Control groups The AMIHOT trial results revealed positive trends for the overall study population in favor of the AO Therapy test group in each of the three co-primary endpoints These favorable results did not demonstrate the required level of statistical significance to claim superiority However an examination of a pre-specified patient subset anterior AMI subjects treated within six hours of symptom onset showed promising results after analysis of the surrogate endpoint data forming the basis for this IDE supplement that requests approval to conduct a new trial focused on this further defined patient population
TherOx has designed a follow-up clinical trial focused on these anterior AMI subjects treated within six hours utilizing a Bayesian statistical design that incorporates both the existing AMIHOT data and the new proposed AMIHOT II study data into a hierarchical model for combined analysis
The key differences between the proposed AMIHOT II study and the previously conducted AMIHOT trial are
Focused target patient population - anterior AMI subjects revascularized within six hours of symptom onset AMIHOT included patients revascularized within 24 hours of symptom onset irrespective of location of infarct
Single effectiveness endpoint - infarct size reduction as measured by 14-day Tc-99m Sestamibi SPECT imaging AMIHOT included 3 co-primary endpoints
Non-inferiority comparison of 30-day MACE rates within a 6 safety delta AMIHOT proposed an 8 delta
Randomization scheme - AMIHOT II will be randomized on a 281 AO Therapy Group Control Group basis as compared to the 11 randomization used in AMIHOT
The method of administration of AO Therapy and the basic design of the AO System and AO Cartridge have not changed since the approval was granted by FDA to conduct the AMIHOT trial The IDE number for the AMIHOT II clinical proposal is consistent with AMIHOT G980257
The pivotal AMIHOT clinical study for the TherOx Aqueous Oxygen AO System in treating post acute myocardial infarction AMI patients was approved by FDA on January 10 2002 under IDE G980257S011 The study objective was to determine whether the adjunctive administration of AO Therapy immediately after successful PCI in a group of patients presenting less than 24 hours from AMI symptom onset improves left ventricular function and reduces the area of infarction with no increased incidence of 30-day Major Adverse Cardiac Events MACE when compared to a control group receiving only PCI standard-of-care treatment 30-day MACE comprises the combined incidence of death reinfarction target vessel revascularization and stroke
Two hundred eighty-nine 289 patients were enrolled from January 16 2002 through December 24 2003 including 20 run-in subjects and 269 randomized patients Three independent biomarkers infarct size reduction regional wall motion score improvement at three months and reduction in ST segment elevation were designated as co-primary endpoints to evaluate the effectiveness of AO Therapy The study was designed to demonstrate superiority of the AO Therapy group as compared to controls for each of these endpoints and to demonstrate non-inferiority of the AO Therapy group as compared to Control with respect to 30-day MACE The study population was comprised of qualifying AMI patients treated with either PCI alone or with AO Therapy as an adjunct to successful PCI within 24 hours of symptom onset
The observed 30-day MACE rates were comparable between the AO Therapy and Control groups The AMIHOT trial results revealed positive trends for the overall study population in favor of the AO Therapy test group in each of the three co-primary endpoints These favorable results did not demonstrate the required level of statistical significance to claim superiority However an examination of a pre-specified patient subset anterior AMI subjects treated within six hours of symptom onset showed promising results after analysis of the surrogate endpoint data forming the basis for this IDE supplement that requests approval to conduct a new trial focused on this further defined patient population
TherOx has designed a follow-up clinical trial focused on these anterior AMI subjects treated within six hours utilizing a Bayesian statistical design that incorporates both the existing AMIHOT data and the new proposed AMIHOT II study data into a hierarchical model for combined analysis
The key differences between the proposed AMIHOT II study and the previously conducted AMIHOT trial are
Focused target patient population - anterior AMI subjects revascularized within six hours of symptom onset AMIHOT included patients revascularized within 24 hours of symptom onset irrespective of location of infarct
Single effectiveness endpoint - infarct size reduction as measured by 14-day Tc-99m Sestamibi SPECT imaging AMIHOT included 3 co-primary endpoints
Non-inferiority comparison of 30-day MACE rates within a 6 safety delta AMIHOT proposed an 8 delta
Randomization scheme - AMIHOT II will be randomized on a 281 AO Therapy Group Control Group basis as compared to the 11 randomization used in AMIHOT
The method of administration of AO Therapy and the basic design of the AO System and AO Cartridge have not changed since the approval was granted by FDA to conduct the AMIHOT trial The IDE number for the AMIHOT II clinical proposal is consistent with AMIHOT G980257
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None