Late Breaking Phase 3 CHAMPION PHOENIX Trial Results Presented at American College of Cardiology Scientific Session and Published in The New England Journal of Medicine
SAN FRANCISCO, CA, USA I March 11, 2013 I The Medicines Company ( NASDAQ : MDCO ) today reported results of CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company’s intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing percutaneous coronary intervention (PCI). Patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization. Cangrelor also showed a 38% reduction in the odds of the key secondary endpoint, incidence of stent thrombosis at 48 hours.
Detailed findings include:
| |
Endpoints at 48 hours |
|
Cangrelor*
(n =5472) |
|
Clopidogrel*
(n = 5470) |
Odds Reduction |
p-value |
| |
Primary Endpoint |
Death/MI/IDR/ST |
4.7% |
|
5.9% |
22% |
0.005 |
| |
Key Secondary |
Stent thrombosis |
0.8% |
|
1.4% |
38% |
0.01 |
| |
MI |
|
3.8% |
|
4.7% |
20% |
0.02 |
| |
QMI |
|
0.2% |
|
0.3% |
39% |
0.19 |
| |
IDR |
|
0.5% |
|
0.7% |
26% |
0.22 |
| |
Death |
|
0.3% |
|
0.3% |
0% |
> 0.999 |
| |
Death or ST |
|
1.1% |
|
1.6% |
33% |
0.02 |
| |
Incidence of primary endpoint in selected subgroups: |
| |
Clopidogrel loading dose |
300 mg (n=2806) |
5.8% |
|
6.8% |
16% |
0.27 |
| 600 mg (n=8133) |
4.3% |
|
5.6% |
23% |
0.009 |
| |
Timing of loading dose |
Before PCI (n=6902) |
4.8% |
|
6.0% |
20% |
0.033 |
| After PCI (n=3976) |
4.3% |
|
5.4% |
21% |
0.12 |
| |
|
|
|
|
|
|
|
*Modified Intention-to-Treat-Population
The findings were consistent across all analyzed subgroups of patients, including age, geography, diagnosis at presentation, and the choice of periprocedural anticoagulant. At 30 days, the rate of the composite primary efficacy end point remained significantly lower in the cangrelor group than in the clopidogrel group and the relative reduction in stent thrombosis also persisted.
Commenting on the results, Simona Skerjanec PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company, said: "With successful completion and reporting of this Phase 3 trial, our next step is to submit for market approvals in the US and Europe. We anticipate submitting these data for a new drug application to the US Food and Drug Administration in the second quarter with findings of prior trials, including the BRIDGE trial in patients awaiting open heart surgery."
Safety findings
The primary safety end point was non-CABG-related severe bleeding, according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria, at 48 hours. Several other bleeding definitions were also applied. More sensitive measures did show an increase in bleeding with cangrelor, though there was no significant difference in the rate of transfusions.
| |
|
|
|
|
|
|
|
|
| |
|
|
|
Cangrelor*
(n =5529) |
|
Clopidogrel*
(n = 5527) |
Odds Ratio
95% CI |
p-value |
| |
Bleeding |
|
|
|
|
|
|
|
| |
GUSTO |
|
Severe |
0.2% |
|
0.1% |
1.50(0.53-4.22) |
0.44 |
| |
|
|
Moderate |
0.4% |
|
0.2% |
1.69(0.85-3.37) |
0.13 |
| |
TIMI |
|
Major |
0.1% |
|
0.1% |
1.00(0.29-3.45) |
> 0.99 |
| |
|
|
Minor |
0.2% |
|
0.1% |
3.00(0.81-11.10) |
0.08 |
| |
|
|
Major or minor |
0.3% |
|
0.1% |
1.75(0.73-4.18) |
0.20 |
| |
ACUITY |
|
Major |
4.3% |
|
2.5% |
1.72(1.39,2.13) |
< 0.001 |
| |
|
|
Major w/out hematoma |
0.8% |
|
0.5% |
1.62(0.99,2.64) |
0.05 |
| |
Any blood transfusion |
0.5% |
|
0.3% |
1.56(0.83-2.93) |
0.16 |
| |
Efficacy and safety: net adverse clinical events** |
| |
Death, myocardial infarction, ischemia-driven revascularization, stent thrombosis, or GUSTO-defined severe bleeding |
4.8% |
|
6.0% |
0.80(0.67-0.94) |
0.008 |
| |
|
|
|
|
|
|
*Safety Population
**The primary efficacy and primary safety end points were combined to provide a composite end point of net adverse clinical events in the modified intention-to-treat population.
The rate of adverse events related to treatment was similar in the cangrelor and clopidogrel groups (20.2% and 19.1%, respectively; P = 0.13). There were significantly more cases of transient dyspnea with cangrelor than with clopidogrel (1.2% vs 0.3%, P < 0.001), a finding that was also observed in the prior CHAMPION studies.
Presentation and Publication of Results
The results were presented at the American College of Cardiology’s 62nd Annual Scientific Session and Expo this morning by Co-Principal Investigator Deepak L. Bhatt, MD, MPH, director of the Integrated Interventional Cardiovascular Program at Brigham and Women’s Hospital (BWH) and chief of cardiology at VA Boston Healthcare System, as well as professor of medicine at Harvard Medical School. The other Co-principal investigator of the CHAMPION Trials was Robert A. Harrington, MD, professor and chair of the Department of Medicine at Stanford. The results were concurrently published today in The New England Journal of Medicine.
Conference Call
There will be a conference call with MDCO management and experts today at 11:00 a.m. Pacific Time (2:00 p.m. Eastern Time) to discuss cangrelor trial results and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at The Medicines Company website at www.themedicinescompany.com. The dial in information is listed below:
Domestic Dial In: 866 700.6067
International Dial In: 617 213.8834
Passcode for both dial in numbers: 54431050
Replay is available from 4:00 p.m. Eastern Time following the conference call through March 17, 2013. To hear a replay of the call, dial 888 286.8010 (domestic) and 617 801.6888 (international). Passcode for both dial in numbers is 17733784.
About Cangrelor
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting including in patients undergoing percutaneous coronary intervention (PCI). The CHAMPION PHOENIX trial is a double-blind parallel group randomized study that compares cangrelor to a clopidogrel loading dose administered as soon as possible after it is determined that the patient will undergo PCI. In 2011, the Company reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent and receiving a thienopyridine awaiting coronary artery bypass graft (CABG) surgery.
About The Medicines Company
The Medicines Company ( NASDAQ : MDCO ) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company’s website is www.themedicinescompany.com.
SOURCE: The Medicines Company
Post Views: 81
Late Breaking Phase 3 CHAMPION PHOENIX Trial Results Presented at American College of Cardiology Scientific Session and Published in The New England Journal of Medicine
SAN FRANCISCO, CA, USA I March 11, 2013 I The Medicines Company ( NASDAQ : MDCO ) today reported results of CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company’s intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing percutaneous coronary intervention (PCI). Patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization. Cangrelor also showed a 38% reduction in the odds of the key secondary endpoint, incidence of stent thrombosis at 48 hours.
Detailed findings include:
| |
Endpoints at 48 hours |
|
Cangrelor*
(n =5472) |
|
Clopidogrel*
(n = 5470) |
Odds Reduction |
p-value |
| |
Primary Endpoint |
Death/MI/IDR/ST |
4.7% |
|
5.9% |
22% |
0.005 |
| |
Key Secondary |
Stent thrombosis |
0.8% |
|
1.4% |
38% |
0.01 |
| |
MI |
|
3.8% |
|
4.7% |
20% |
0.02 |
| |
QMI |
|
0.2% |
|
0.3% |
39% |
0.19 |
| |
IDR |
|
0.5% |
|
0.7% |
26% |
0.22 |
| |
Death |
|
0.3% |
|
0.3% |
0% |
> 0.999 |
| |
Death or ST |
|
1.1% |
|
1.6% |
33% |
0.02 |
| |
Incidence of primary endpoint in selected subgroups: |
| |
Clopidogrel loading dose |
300 mg (n=2806) |
5.8% |
|
6.8% |
16% |
0.27 |
| 600 mg (n=8133) |
4.3% |
|
5.6% |
23% |
0.009 |
| |
Timing of loading dose |
Before PCI (n=6902) |
4.8% |
|
6.0% |
20% |
0.033 |
| After PCI (n=3976) |
4.3% |
|
5.4% |
21% |
0.12 |
| |
|
|
|
|
|
|
|
*Modified Intention-to-Treat-Population
The findings were consistent across all analyzed subgroups of patients, including age, geography, diagnosis at presentation, and the choice of periprocedural anticoagulant. At 30 days, the rate of the composite primary efficacy end point remained significantly lower in the cangrelor group than in the clopidogrel group and the relative reduction in stent thrombosis also persisted.
Commenting on the results, Simona Skerjanec PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company, said: "With successful completion and reporting of this Phase 3 trial, our next step is to submit for market approvals in the US and Europe. We anticipate submitting these data for a new drug application to the US Food and Drug Administration in the second quarter with findings of prior trials, including the BRIDGE trial in patients awaiting open heart surgery."
Safety findings
The primary safety end point was non-CABG-related severe bleeding, according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria, at 48 hours. Several other bleeding definitions were also applied. More sensitive measures did show an increase in bleeding with cangrelor, though there was no significant difference in the rate of transfusions.
| |
|
|
|
|
|
|
|
|
| |
|
|
|
Cangrelor*
(n =5529) |
|
Clopidogrel*
(n = 5527) |
Odds Ratio
95% CI |
p-value |
| |
Bleeding |
|
|
|
|
|
|
|
| |
GUSTO |
|
Severe |
0.2% |
|
0.1% |
1.50(0.53-4.22) |
0.44 |
| |
|
|
Moderate |
0.4% |
|
0.2% |
1.69(0.85-3.37) |
0.13 |
| |
TIMI |
|
Major |
0.1% |
|
0.1% |
1.00(0.29-3.45) |
> 0.99 |
| |
|
|
Minor |
0.2% |
|
0.1% |
3.00(0.81-11.10) |
0.08 |
| |
|
|
Major or minor |
0.3% |
|
0.1% |
1.75(0.73-4.18) |
0.20 |
| |
ACUITY |
|
Major |
4.3% |
|
2.5% |
1.72(1.39,2.13) |
< 0.001 |
| |
|
|
Major w/out hematoma |
0.8% |
|
0.5% |
1.62(0.99,2.64) |
0.05 |
| |
Any blood transfusion |
0.5% |
|
0.3% |
1.56(0.83-2.93) |
0.16 |
| |
Efficacy and safety: net adverse clinical events** |
| |
Death, myocardial infarction, ischemia-driven revascularization, stent thrombosis, or GUSTO-defined severe bleeding |
4.8% |
|
6.0% |
0.80(0.67-0.94) |
0.008 |
| |
|
|
|
|
|
|
*Safety Population
**The primary efficacy and primary safety end points were combined to provide a composite end point of net adverse clinical events in the modified intention-to-treat population.
The rate of adverse events related to treatment was similar in the cangrelor and clopidogrel groups (20.2% and 19.1%, respectively; P = 0.13). There were significantly more cases of transient dyspnea with cangrelor than with clopidogrel (1.2% vs 0.3%, P < 0.001), a finding that was also observed in the prior CHAMPION studies.
Presentation and Publication of Results
The results were presented at the American College of Cardiology’s 62nd Annual Scientific Session and Expo this morning by Co-Principal Investigator Deepak L. Bhatt, MD, MPH, director of the Integrated Interventional Cardiovascular Program at Brigham and Women’s Hospital (BWH) and chief of cardiology at VA Boston Healthcare System, as well as professor of medicine at Harvard Medical School. The other Co-principal investigator of the CHAMPION Trials was Robert A. Harrington, MD, professor and chair of the Department of Medicine at Stanford. The results were concurrently published today in The New England Journal of Medicine.
Conference Call
There will be a conference call with MDCO management and experts today at 11:00 a.m. Pacific Time (2:00 p.m. Eastern Time) to discuss cangrelor trial results and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at The Medicines Company website at www.themedicinescompany.com. The dial in information is listed below:
Domestic Dial In: 866 700.6067
International Dial In: 617 213.8834
Passcode for both dial in numbers: 54431050
Replay is available from 4:00 p.m. Eastern Time following the conference call through March 17, 2013. To hear a replay of the call, dial 888 286.8010 (domestic) and 617 801.6888 (international). Passcode for both dial in numbers is 17733784.
About Cangrelor
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting including in patients undergoing percutaneous coronary intervention (PCI). The CHAMPION PHOENIX trial is a double-blind parallel group randomized study that compares cangrelor to a clopidogrel loading dose administered as soon as possible after it is determined that the patient will undergo PCI. In 2011, the Company reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent and receiving a thienopyridine awaiting coronary artery bypass graft (CABG) surgery.
About The Medicines Company
The Medicines Company ( NASDAQ : MDCO ) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company’s website is www.themedicinescompany.com.
SOURCE: The Medicines Company
Post Views: 81
