AtherosclerosisPhase 3CHAMPIONNCT01156571

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

A Phase 3 study testing cangrelor P2Y12 (platelet) inhibitor, Clopidogrel - 300 or 600 mg (study arm) and Clopidogrel 600 mg post cangrelor in people with Atherosclerosis and Percutaneous Coronary Intervention, run by The Medicines Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atherosclerosis, Percutaneous Coronary Intervention, Acute Coronary Syndrome
What is being tested?: cangrelor P2Y12 (platelet) inhibitor, Clopidogrel - 300 or 600 mg (study arm) and Clopidogrel 600 mg post cangrelor
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11,145 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Dec 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients may be included in the study if they meet all of the following criteria:
Male or non-pregnant female at least 18 years of age
Patients undergoing percutaneous coronary intervention (PCI):
Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)
Provide written informed consent

Who cannot join

Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
Abciximab usage within 7 days preceding randomization
Receipt of fibrinolytic therapy in the 12 hours preceding randomization
Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke; tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); currently receiving warfarin; active bleeding

Trial locations and contacts

1 site in 1 country.

United States1 site

Anderson Area Medical Center
Anderson, South Carolina, 29621

Other trials in United States

About this study

Official title: A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)

The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).

Conditions: Atherosclerosis, Percutaneous Coronary Intervention, Acute Coronary Syndrome
Being tested: cangrelor P2Y12 (platelet) inhibitor, Clopidogrel - 300 or 600 mg (study arm), Clopidogrel 600 mg post cangrelor
Medical subject headings: Atherosclerosis, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cangrelor P2Y12 (platelet) inhibitorDrug
Clopidogrel - 300 or 600 mg (study arm)Drug
Over encapsulated tablets.
Clopidogrel 600 mg post cangrelorDrug
over-encapsulated clopidogrel (600 mg)

Study groups in NCT01156571
Study group	Role	What they receive
cangrelor	Experimental	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. Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered. Receives: Drug: cangrelor P2Y12 (platelet) inhibitor; Drug: Clopidogrel 600 mg post cangrelor
clopidogrel	Active comparator	Clopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion. During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm. Receives: Drug: Clopidogrel - 300 or 600 mg (study arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)
Measured: 48 hours after randomization

Secondary outcomes (2)

Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)
CEC-adjudicated results (mITT population)
Measured: 48 hours after randomization
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild
GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial
Measured: 48 hours after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Dec 2012

First posted5 Jul 2010 (estimated)
Study startSep 2010
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (21)Papers the sponsor has linked to this study.
Other trials for AtherosclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 11,145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01156571
Sponsor's protocol ID: TMC-CAN-10-01
Acronym: CHAMPION
Status last verified: Jan 2014
First submitted: 29 Jun 2010
Last updated: 4 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Gutierrez JA, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL; CHAMPION Investigators. Efficacy and safety of cangrelor in patients with peripheral artery disease undergoing percutaneous coronary intervention - Insights from the CHAMPION program. Am Heart J Plus. 2021 Aug 25;9:100043. doi: 10.1016/j.ahjo.2021.100043. eCollection 2021 Sep.
PubMed 38551015
Peterson BE, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL. Effect of Platelet Inhibition by Cangrelor Among Obese Patients Undergoing Coronary Stenting: Insights From CHAMPION. Circ Cardiovasc Interv. 2022 Mar;15(3):e011069. doi: 10.1161/CIRCINTERVENTIONS.121.011069. Epub 2022 Feb 24.
PubMed 35196863
Cavender MA, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Deliargyris EN, Prats J, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators*. Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX. Circ Cardiovasc Interv. 2022 Jan;15(1):e010390. doi: 10.1161/CIRCINTERVENTIONS.120.010390. Epub 2021 Dec 17.
PubMed 34915723
Olivier CB, Bhatt DL, Leonardi S, Stone GW, Gibson CM, Steg PG, Hamm CW, Wilson MD, Mangum S, Price MJ, Prats J, White HD, Lopes RD, Harrington RA, Mahaffey KW; CHAMPION PHOENIX Investigators *. Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019 Jul;12(7):e007342. doi: 10.1161/CIRCINTERVENTIONS.118.007342. Epub 2019 Jul 12.
PubMed 31296081
Abtan J, Ducrocq G, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm CW, Price MJ, Prats J, Deliargyris EN, White HD, Harrington RA, Bhatt DL. Periprocedural Outcomes According to Timing of Clopidogrel Loading Dose in Patients Who Did Not Receive P2Y12 Inhibitor Pretreatment. Circ Cardiovasc Interv. 2019 Mar;12(3):e007445. doi: 10.1161/CIRCINTERVENTIONS.118.007445.
PubMed 30871355
Abtan J, Ducrocq G, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm C, Price MJ, Prats J, Elkin S, Deliargyris EN, White HD, Menozzi A, Harrington RA, Bhatt DL; MPH on Behalf of the CHAMPION PHOENIX Investigators. Characteristics and outcomes of patients requiring bailout use of glycoprotein IIb/IIIa inhibitors for thrombotic complications of percutaneous coronary intervention: An analysis from the CHAMPION PHOENIX trial. Int J Cardiol. 2019 Mar 1;278:217-222. doi: 10.1016/j.ijcard.2018.11.114. Epub 2018 Nov 23.
PubMed 30563770
Stone GW, Genereux P, Harrington RA, White HD, Gibson CM, Steg PG, Hamm CW, Mahaffey KW, Price MJ, Prats J, Deliargyris EN, Bhatt DL. Impact of lesion complexity on peri-procedural adverse events and the benefit of potent intravenous platelet adenosine diphosphate receptor inhibition after percutaneous coronary intervention: core laboratory analysis from 10 854 patients from the CHAMPION PHOENIX trial. Eur Heart J. 2018 Dec 7;39(46):4112-4121. doi: 10.1093/eurheartj/ehy562.
PubMed 30203006
Groves EM, Bhatt DL, Steg PG, Deliargyris EN, Stone GW, Gibson CM, Hamm CW, Mahaffey KW, White HD, Angiolillo DJ, Prats J, Harrington RA, Price MJ. Incidence, Predictors, and Outcomes of Acquired Thrombocytopenia After Percutaneous Coronary Intervention: A Pooled, Patient-Level Analysis of the CHAMPION Trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). Circ Cardiovasc Interv. 2018 Apr;11(4):e005635. doi: 10.1161/CIRCINTERVENTIONS.117.005635.
PubMed 29632238
Vaduganathan M, Harrington RA, Stone GW, Steg G, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Deliargyris EN, Prats J, Mahaffey KW, White HD, Bhatt DL. Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials. EuroIntervention. 2018 Feb 2;13(15):e1841-e1849. doi: 10.4244/EIJ-D-17-00723.
PubMed 28988157
Cavender MA, Bhatt DL, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Prats J, Elkin S, Deliargyris EN, Mahaffey KW, White HD, Harrington RA; CHAMPION PHOENIX Investigators*. Cangrelor in Older Patients Undergoing Percutaneous Coronary Intervention: Findings From CHAMPION PHOENIX. Circ Cardiovasc Interv. 2017 Aug;10(8):e005257. doi: 10.1161/CIRCINTERVENTIONS.117.005257.
PubMed 28801539
Parker WA, Bhatt DL, Prats J, Day JRS, Steg PG, Stone GW, Hamm CW, Mahaffey KW, Price MJ, Gibson CM, White HD, Storey RF; CHAMPION PHOENIX Investigators. Characteristics of dyspnoea and associated clinical outcomes in the CHAMPION PHOENIX study. Thromb Haemost. 2017 Jun 2;117(6):1093-1100. doi: 10.1160/TH16-12-0958. Epub 2017 Apr 6.
PubMed 28382371
Vaduganathan M, Harrington RA, Stone GW, Deliargyris EN, Steg PG, Gibson CM, Hamm CW, Price MJ, Menozzi A, Prats J, Elkin S, Mahaffey KW, White HD, Bhatt DL; CHAMPION Investigators. Cangrelor With and Without Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Jan 17;69(2):176-185. doi: 10.1016/j.jacc.2016.10.055.
PubMed 28081827
Vaduganathan M, Harrington RA, Stone GW, Deliargyris EN, Steg PG, Gibson CM, Hamm CW, Price MJ, Menozzi A, Prats J, Elkin S, Mahaffey KW, White HD, Bhatt DL. Evaluation of Ischemic and Bleeding Risks Associated With 2 Parenteral Antiplatelet Strategies Comparing Cangrelor With Glycoprotein IIb/IIIa Inhibitors: An Exploratory Analysis From the CHAMPION Trials. JAMA Cardiol. 2017 Feb 1;2(2):127-135. doi: 10.1001/jamacardio.2016.4556.
PubMed 27902833
Abtan J, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm CW, Price MJ, Abnousi F, Prats J, Deliargyris EN, White HD, Harrington RA, Bhatt DL; CHAMPION PHOENIX Investigators. Efficacy and Safety of Cangrelor in Preventing Periprocedural Complications in Patients With Stable Angina and Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: The CHAMPION PHOENIX Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1905-13. doi: 10.1016/j.jcin.2016.06.046.
PubMed 27659566
Cavender MA, Bhatt DL, Stone GW, White HD, Steg PG, Gibson CM, Hamm CW, Price MJ, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, Harrington RA; CHAMPION PHOENIX Investigators*. Consistent Reduction in Periprocedural Myocardial Infarction With Cangrelor as Assessed by Multiple Definitions: Findings From CHAMPION PHOENIX (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). Circulation. 2016 Sep 6;134(10):723-33. doi: 10.1161/CIRCULATIONAHA.115.020829. Epub 2016 Aug 1.
PubMed 27482008

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)
ClinicalTrials.gov ID: NCT01156571
Acronym / sponsor ID: CHAMPION / TMC-CAN-10-01
Conditions: Atherosclerosis, Percutaneous Coronary Intervention, Acute Coronary Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 11,145 participants (actual)
Lead sponsor: The Medicines CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 5 Jul 2010 (estimated)
Results: Posted 18 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
cangrelor	Experimental	Drug: cangrelor P2Y12 (platelet) inhibitor, Drug: Clopidogrel 600 mg post cangrelorCangrelor 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. Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered.
clopidogrel	Active comparator	Drug: Clopidogrel - 300 or 600 mg (study arm)Clopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion. During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or non-pregnant female at least 18 years of age
Patients undergoing percutaneous coronary intervention (PCI):
Provide written informed consent

Key exclusion criteria (6 listed)

Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
Abciximab usage within 7 days preceding randomization
Receipt of fibrinolytic therapy in the 12 hours preceding randomization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cangrelor P2Y12 (platelet) inhibitor	Drug	cangrelor
Clopidogrel - 300 or 600 mg (study arm)Over encapsulated tablets.	Drug	clopidogrel
Clopidogrel 600 mg post cangrelorover-encapsulated clopidogrel (600 mg)	Drug	cangrelor

Primary outcome

The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
Time frame: 48 hours after randomization
Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)

2 secondary outcomes

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

Results and safety

Results posted to the registry on 18 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cangrelor Treatment Arm	5,581	5,564
Clopidogrel Treatment Arm	5,564	5,545

Primary outcome: The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)

Time frame: 48 hours after randomization. Number. Unit: participants

Measure	Cangrelor Treatment Arm n = 5470	Clopidogrel Treatment Arm n = 5469
Value	257	322

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cangrelor Treatment Arm	122 of 5,529 (2.2%)	0 of 5,529 (0%)	Not reported
Clopidogrel Treatment Arm	105 of 5,527 (1.9%)	0 of 5,527 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38551015Gutierrez JA, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL; CHAMPION Investigators. Efficacy and safety of cangrelor in patients with peripheral artery disease undergoing percutaneous coronary intervention - Insights from the CHAMPION program. Am Heart J Plus. 2021 Aug 25;9:100043. doi: 10.1016/j.ahjo.2021.100043. eCollection 2021 Sep.
Derived from this study: PubMed 35196863Peterson BE, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL. Effect of Platelet Inhibition by Cangrelor Among Obese Patients Undergoing Coronary Stenting: Insights From CHAMPION. Circ Cardiovasc Interv. 2022 Mar;15(3):e011069. doi: 10.1161/CIRCINTERVENTIONS.121.011069. Epub 2022 Feb 24.
Derived from this study: PubMed 34915723Cavender MA, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Deliargyris EN, Prats J, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators*. Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX. Circ Cardiovasc Interv. 2022 Jan;15(1):e010390. doi: 10.1161/CIRCINTERVENTIONS.120.010390. Epub 2021 Dec 17.
Derived from this study: PubMed 31296081Olivier CB, Bhatt DL, Leonardi S, Stone GW, Gibson CM, Steg PG, Hamm CW, Wilson MD, Mangum S, Price MJ, Prats J, White HD, Lopes RD, Harrington RA, Mahaffey KW; CHAMPION PHOENIX Investigators *. Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019 Jul;12(7):e007342. doi: 10.1161/CIRCINTERVENTIONS.118.007342. Epub 2019 Jul 12.
Derived from this study: PubMed 30871355Abtan J, Ducrocq G, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm CW, Price MJ, Prats J, Deliargyris EN, White HD, Harrington RA, Bhatt DL. Periprocedural Outcomes According to Timing of Clopidogrel Loading Dose in Patients Who Did Not Receive P2Y12 Inhibitor Pretreatment. Circ Cardiovasc Interv. 2019 Mar;12(3):e007445. doi: 10.1161/CIRCINTERVENTIONS.118.007445.
Derived from this study: PubMed 30563770Abtan J, Ducrocq G, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm C, Price MJ, Prats J, Elkin S, Deliargyris EN, White HD, Menozzi A, Harrington RA, Bhatt DL; MPH on Behalf of the CHAMPION PHOENIX Investigators. Characteristics and outcomes of patients requiring bailout use of glycoprotein IIb/IIIa inhibitors for thrombotic complications of percutaneous coronary intervention: An analysis from the CHAMPION PHOENIX trial. Int J Cardiol. 2019 Mar 1;278:217-222. doi: 10.1016/j.ijcard.2018.11.114. Epub 2018 Nov 23.
Derived from this study: PubMed 30203006Stone GW, Genereux P, Harrington RA, White HD, Gibson CM, Steg PG, Hamm CW, Mahaffey KW, Price MJ, Prats J, Deliargyris EN, Bhatt DL. Impact of lesion complexity on peri-procedural adverse events and the benefit of potent intravenous platelet adenosine diphosphate receptor inhibition after percutaneous coronary intervention: core laboratory analysis from 10 854 patients from the CHAMPION PHOENIX trial. Eur Heart J. 2018 Dec 7;39(46):4112-4121. doi: 10.1093/eurheartj/ehy562.
Derived from this study: PubMed 29632238Groves EM, Bhatt DL, Steg PG, Deliargyris EN, Stone GW, Gibson CM, Hamm CW, Mahaffey KW, White HD, Angiolillo DJ, Prats J, Harrington RA, Price MJ. Incidence, Predictors, and Outcomes of Acquired Thrombocytopenia After Percutaneous Coronary Intervention: A Pooled, Patient-Level Analysis of the CHAMPION Trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). Circ Cardiovasc Interv. 2018 Apr;11(4):e005635. doi: 10.1161/CIRCINTERVENTIONS.117.005635.
Derived from this study: PubMed 28988157Vaduganathan M, Harrington RA, Stone GW, Steg G, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Deliargyris EN, Prats J, Mahaffey KW, White HD, Bhatt DL. Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials. EuroIntervention. 2018 Feb 2;13(15):e1841-e1849. doi: 10.4244/EIJ-D-17-00723.
Derived from this study: PubMed 28801539Cavender MA, Bhatt DL, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Prats J, Elkin S, Deliargyris EN, Mahaffey KW, White HD, Harrington RA; CHAMPION PHOENIX Investigators*. Cangrelor in Older Patients Undergoing Percutaneous Coronary Intervention: Findings From CHAMPION PHOENIX. Circ Cardiovasc Interv. 2017 Aug;10(8):e005257. doi: 10.1161/CIRCINTERVENTIONS.117.005257.
Derived from this study: PubMed 28382371Parker WA, Bhatt DL, Prats J, Day JRS, Steg PG, Stone GW, Hamm CW, Mahaffey KW, Price MJ, Gibson CM, White HD, Storey RF; CHAMPION PHOENIX Investigators. Characteristics of dyspnoea and associated clinical outcomes in the CHAMPION PHOENIX study. Thromb Haemost. 2017 Jun 2;117(6):1093-1100. doi: 10.1160/TH16-12-0958. Epub 2017 Apr 6.
Derived from this study: PubMed 28081827Vaduganathan M, Harrington RA, Stone GW, Deliargyris EN, Steg PG, Gibson CM, Hamm CW, Price MJ, Menozzi A, Prats J, Elkin S, Mahaffey KW, White HD, Bhatt DL; CHAMPION Investigators. Cangrelor With and Without Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Jan 17;69(2):176-185. doi: 10.1016/j.jacc.2016.10.055.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) (time frame: 48 hours after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01156571, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.