A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Atherosclerosis Percutaneous Coronary Intervention Acute Coronary Syndrome
Interventions:	Drug: cangrelor P2Y12 (platelet) inhibitor Drug: Clopidogrel - 300 or 600 mg (study arm) Drug: Clopidogrel 600 mg post cangrelor

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date first patient enrolled: 30 Sep 2010 Date last patient completed: 14 Nov 2012 This trial enrolled the full spectrum of patients who required PCI (SA, NSTE-ACS, STEMI). Randomization occurred after confirmation of need for PCI (after diagnostic angiogram in all cases, except for STEMI patients). Patients were followed through 30-days.

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Date first patient enrolled: 30 Sep 2010 Date last patient completed: 14 Nov 2012

This trial enrolled the full spectrum of patients who required PCI (SA, NSTE-ACS, STEMI). Randomization occurred after confirmation of need for PCI (after diagnostic angiogram in all cases, except for STEMI patients). Patients were followed through 30-days.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to the nature of the disease, STEMI patients were permitted to be randomized upon ECG confirmation and prior to confirmation of need for PCI (prior to diagnostic angiography). Therefore in some cases, STEMI patients did not require PCI and therefore did not receive all study drug.

Reporting Groups

	Description
Cangrelor Treatment Arm	Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered. Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.
Clopidogrel Treatment Arm	Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator. Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.

Description

Cangrelor Treatment Arm

Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.

Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.

Clopidogrel Treatment Arm

Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.

Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.

Participant Flow: Overall Study

	Cangrelor Treatment Arm	Clopidogrel Treatment Arm
STARTED	5581 ^[1]	5564 ^[1]
COMPLETED	5564 ^[2]	5545 ^[2]
NOT COMPLETED	17	19

[1]	ITT: defined as all patients randomized.
[2]	Completed = ITT patients who completed scheduled visits or developed a primary endpoint event

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population

Reporting Groups

	Description
Cangrelor Treatment Arm	Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered. Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.
Clopidogrel Treatment Arm	Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator. Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.
Total	Total of all reporting groups

Description

Cangrelor Treatment Arm

Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.

Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.

Clopidogrel Treatment Arm

Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.

Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.

Total

Total of all reporting groups

Baseline Measures

	Cangrelor Treatment Arm	Clopidogrel Treatment Arm	Total
Number of Participants [units: participants]	5581	5564	11145
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	2892	2902	5794
>=65 years	2689	2662	5351
Age [units: years] Mean ± Standard Deviation	64.0 ± 11.0	63.8 ± 11.0	63.9 ± 11.0
Gender [units: participants]
Female	1599	1522	3121
Male	3982	4042	8024
Region of Enrollment [units: participants]
United States	2099	2089	4188
Austria	302	300	602
Brazil	78	80	158
Bulgaria	169	167	336
Czech Republic	814	816	1630
Georgia	744	741	1485
Germany	243	251	494
Italy	311	310	621
New Zealand	22	23	45
Poland	352	350	702
Russian Federation	296	286	582
Thailand	151	151	302

Outcome Measures

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1. Primary:

The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) [ Time Frame: 48 hours after randomization ]

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2. Secondary:

Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) [ Time Frame: 48 hours after randomization ]

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3. Secondary:

Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild [ Time Frame: 48 hours after randomization ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

In general, PI communications regarding trial results are prohibited until after the communication and publication of the multi-center results by Sponsor, but no more than 12 months after conclusion of the trial at all sites.

PI must submit results communications to sponsor for review at least 45 days prior to submission for publication and Sponsor may embargo such communications for a period that is less than or equal to 135 days solely to seek appropriate patent protection.

Results Point of Contact:

Name/Title: Meredith Todd - Sr. Director Program Management
Organization: The Medicines Company
phone: +1.973.290.6088
e-mail: meredith.todd@themedco.com

No publications provided by The Medicines Company

Publications automatically indexed to this study:

Généreux P, Stone GW, Harrington RA, Gibson CM, Steg PG, Brener SJ, Angiolillo DJ, Price MJ, Prats J, Lasalle L, Liu T, Todd M, Skerjanec S, Hamm CW, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators. Impact of intraprocedural stent thrombosis during percutaneous coronary intervention: insights from the CHAMPION PHOENIX Trial (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). J Am Coll Cardiol. 2014 Feb 25;63(7):619-29. doi: 10.1016/j.jacc.2013.10.022. Epub 2013 Oct 30.

Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimský P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Généreux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013 Apr 4;368(14):1303-13. doi: 10.1056/NEJMoa1300815. Epub 2013 Mar 10.

Leonardi S, Mahaffey KW, White HD, Gibson CM, Stone GW, Steg GW, Hamm CW, Price MJ, Todd M, Dietrich M, Gallup D, Liu T, Skerjanec S, Harrington RA, Bhatt DL. Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial. Am Heart J. 2012 May;163(5):768-776.e2. doi: 10.1016/j.ahj.2012.02.018.

Responsible Party:	The Medicines Company
ClinicalTrials.gov Identifier:	NCT01156571 History of Changes
Other Study ID Numbers:	TMC-CAN-10-01
Study First Received:	June 29, 2010
Results First Received:	April 22, 2013
Last Updated:	January 2, 2014
Health Authority:	United States: Food and Drug Administration