AtherosclerosisPhase 3PlatformNCT00385138

Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.

A Phase 3 study testing Cangrelor and clopidogrel in people with Atherosclerosis and Acute Coronary Syndrome (ACS), run by The Medicines Company at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia-driven… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atherosclerosis, Acute Coronary Syndrome (ACS)
What is being tested?: Cangrelor and clopidogrel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5,364 participants
Where: 1 siteUnited States
Study dates: Sep 2006to Jun 2010
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

Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age > 65 or diabetes.

Who cannot join

Not a candidate for PCI
ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization
Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery [including coronary artery bypass graft (CABG) surgery]; currently receiving warfarin, active bleeding
Impaired hemostasis: known International Normalized Ratio (INR) >1.5 at screening; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL) at screening
Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
Receipt of fibrinolytic therapy in the 12 hours preceding randomization
Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization
Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients]

Trial locations and contacts

1 site in 1 country.

United States1 site

Innovis Health
Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: A Clinical Trial Comparing Treatment With Cangrelor (in Combination With Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention (PCI).

Conditions: Atherosclerosis, Acute Coronary Syndrome (ACS)
Being tested: Cangrelor, clopidogrel, Placebo bolus & placebo infusion, Placebo capsules - end of PCI, Placebo capsules - end of infusion
Keywords: Percutaneous Coronary Intervention (PCI), ACS
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.

CangrelorDrug
cangrelor bolus (30 mcg/kg) \& cangrelor infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
clopidogrelDrug
Also called Plavix
clopidogrel capsules (600 mg) at end of PCI
Placebo bolus & placebo infusionDrug
placebo bolus (30 mcg/kg) \& placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
Placebo capsules - end of PCIDrug
Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing
Placebo capsules - end of infusionDrug
Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing

Study groups in NCT00385138
Study group	Role	What they receive
Cangrelor	Experimental	cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion Receives: Drug: Cangrelor; Drug: clopidogrel; Drug: Placebo capsules - end of PCI
Clopidogrel	Active comparator	placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion Receives: Drug: clopidogrel; Drug: Placebo bolus & placebo infusion; Drug: Placebo capsules - end of infusion

What is being measured

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

Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
mITT population; (composite incidence)
Measured: randomization through 48 hours post randomization

Secondary outcomes (19)

Incidence of All-cause Mortality or MI
mITT population
Measured: randomization through 48 hours post randomization
Incidence of All-cause Mortality
mITT population
Measured: randomization through 48 hours post randomization
Incidence of MI
mITT population
Measured: randomization through 48 hours post randomization
Incidence of IDR
mITT population
Measured: randomization through 48 hours post randomization
Incidence of Stent Thrombosis
mITT population
Measured: randomization through 48 hours post randomization
Incidence of Stroke
mITT
Measured: randomization through 48 hours post randomization
Incidence of All-cause Mortality
mITT population
Measured: randomization through 1 year post randomization
Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]
mITT population A patient could have multiple procedural events.
Measured: During index PCI
Incidence of GUSTO Severe / Life-threatening
Major bleeding (non-CABG-related) - Safety population
Measured: randomization through 48 hours post randomization
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
Major bleeding (non-CABG-related) - Safety population
Measured: randomization through 48 hours post randomization
Incidence of ACUITY Major Bleeding
Major bleeding (non-CABG-related) - Safety population
Measured: randomization through 48 hours post randomization
Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm.
Measured: randomization through 48 hours post randomization
Incidence of All-cause Mortality, MI, or IDR
mITT population
Measured: randomization through 30 days post randomization
Incidence of All-cause Mortality or MI
mITT population
Measured: randomization through 30 days post randomization
Incidence of All-cause Mortality
mITT population
Measured: randomization through 30 days post randomization
Incidence of MI
mITT population
Measured: randomization through 30 days post randomization
Incidence of IDR
mITT population
Measured: randomization through 30 days post randomization
Incidence of Stent Thrombosis
mITT population
Measured: randomization through 30 days post randomization
Incidence of Stroke
mITT population
Measured: randomization through 30 days post randomization

Timeline

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

Sep 2006Jun 2010

First posted6 Oct 2006 (estimated)
Study startSep 2006
Primary completionMay 2009
Study completionJun 2010

Why it stopped: Insufficient evidence of the clinical effectiveness of cangrelor

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 (8)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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 5,364 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00385138
Sponsor's protocol ID: TMC-CAN-05-03
Acronym: Platform
Status last verified: Apr 2014
First submitted: 4 Oct 2006
Last updated: 5 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bhatt DL, Lincoff AM, Gibson CM, Stone GW, McNulty S, Montalescot G, Kleiman NS, Goodman SG, White HD, Mahaffey KW, Pollack CV Jr, Manoukian SV, Widimsky P, Chew DP, Cura F, Manukov I, Tousek F, Jafar MZ, Arneja J, Skerjanec S, Harrington RA; CHAMPION PLATFORM Investigators. Intravenous platelet blockade with cangrelor during PCI. N Engl J Med. 2009 Dec 10;361(24):2330-41. doi: 10.1056/NEJMoa0908629.
PubMed 19915222
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
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
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. 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
White HD, Chew DP, Dauerman HL, Mahaffey KW, Gibson CM, Stone GW, Gruberg L, Harrington RA, Bhatt DL. Reduced immediate ischemic events with cangrelor in PCI: a pooled analysis of the CHAMPION trials using the universal definition of myocardial infarction. Am Heart J. 2012 Feb;163(2):182-90.e4. doi: 10.1016/j.ahj.2011.11.001.
PubMed 22305835

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?

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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial Comparing Treatment With Cangrelor (in Combination With Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention (PCI).
ClinicalTrials.gov ID: NCT00385138
Acronym / sponsor ID: Platform / TMC-CAN-05-03
Conditions: Atherosclerosis, Acute Coronary Syndrome (ACS)
Keywords: Percutaneous Coronary Intervention (PCI), ACS
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient evidence of the clinical effectiveness of cangrelor
Enrolment: 5,364 participants (actual)
Lead sponsor: The Medicines CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: May 2009 (actual)
Study completion: Jun 2010 (actual)
First posted: 6 Oct 2006 (estimated)
Results: Posted 21 Apr 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
Cangrelor	Experimental	Drug: Cangrelor, Drug: clopidogrel, Drug: Placebo capsules - end of PCIcangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
Clopidogrel	Active comparator	Drug: clopidogrel, Drug: Placebo bolus & placebo infusion, Drug: Placebo capsules - end of infusionplacebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion

Who may qualify

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

Key inclusion criteria (1 listed)

Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age > 65 or diabetes.

Key exclusion criteria (8 listed)

Not a candidate for PCI
ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization
Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery [including coronary artery bypass graft (CABG) surgery]; currently receiving warfarin, active bleeding
Impaired hemostasis: known International Normalized Ratio (INR) >1.5 at screening; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL) at screening
Severe hypertension not adequately controlled by antihypertensive therapy at the time of 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
Cangrelorcangrelor bolus (30 mcg/kg) \& cangrelor infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)	Drug	Cangrelor
clopidogrelAlso: Plavixclopidogrel capsules (600 mg) at end of PCI	Drug	Cangrelor, Clopidogrel
Placebo bolus & placebo infusionplacebo bolus (30 mcg/kg) \& placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)	Drug	Clopidogrel
Placebo capsules - end of PCIPlacebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing	Drug	Cangrelor
Placebo capsules - end of infusionPlacebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing	Drug	Clopidogrel

Primary outcome

Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
Time frame: randomization through 48 hours post randomization
mITT population; (composite incidence)

19 secondary outcomes

Incidence of All-cause Mortality or MI
Time frame: randomization through 48 hours post randomization
Incidence of All-cause Mortality
Time frame: randomization through 48 hours post randomization
Incidence of MI
Time frame: randomization through 48 hours post randomization
Incidence of IDR
Time frame: randomization through 48 hours post randomization
Incidence of Stent Thrombosis
Time frame: randomization through 48 hours post randomization
Incidence of Stroke
Time frame: randomization through 48 hours post randomization
Incidence of All-cause Mortality
Time frame: randomization through 1 year post randomization
Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]
Time frame: During index PCI
Incidence of GUSTO Severe / Life-threatening
Time frame: randomization through 48 hours post randomization
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
Time frame: randomization through 48 hours post randomization
Incidence of ACUITY Major Bleeding
Time frame: randomization through 48 hours post randomization
Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
Time frame: randomization through 48 hours post randomization
Incidence of All-cause Mortality, MI, or IDR
Time frame: randomization through 30 days post randomization
Incidence of All-cause Mortality or MI
Time frame: randomization through 30 days post randomization
Incidence of All-cause Mortality
Time frame: randomization through 30 days post randomization
Incidence of MI
Time frame: randomization through 30 days post randomization
Incidence of IDR
Time frame: randomization through 30 days post randomization
Incidence of Stent Thrombosis
Time frame: randomization through 30 days post randomization
Incidence of Stroke
Time frame: randomization through 30 days post randomization

Results and safety

Results posted to the registry on 21 Apr 2014, 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	2,695	2,665
Clopidogrel	2,669	2,641

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

Time frame: randomization through 48 hours post randomization. Number. Unit: participants

Measure	Cangrelor n = 2654	Clopidogrel n = 2641
Value	185	210

Population analysed: mITT population, based on available data

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through 48 hours after study drug initiation. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cangrelor	48 of 2,662 (1.8%)	596 of 2,662 (22.4%)	Not reported
Clopidogrel	55 of 2,650 (2.1%)	530 of 2,650 (20%)	Not reported

Limitations and caveats (from the sponsor): Discontinued per prespecified stopping rules after the 70% interim analyses was conducted indicating the trial was not likely not meet the goal of demonstrating superiority to clopidogrel administered as usual care. No safety issues were identified.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19915222Bhatt DL, Lincoff AM, Gibson CM, Stone GW, McNulty S, Montalescot G, Kleiman NS, Goodman SG, White HD, Mahaffey KW, Pollack CV Jr, Manoukian SV, Widimsky P, Chew DP, Cura F, Manukov I, Tousek F, Jafar MZ, Arneja J, Skerjanec S, Harrington RA; CHAMPION PLATFORM Investigators. Intravenous platelet blockade with cangrelor during PCI. N Engl J Med. 2009 Dec 10;361(24):2330-41. doi: 10.1056/NEJMoa0908629.
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 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 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 27902833Vaduganathan 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.
Derived from this study: PubMed 22305835White HD, Chew DP, Dauerman HL, Mahaffey KW, Gibson CM, Stone GW, Gruberg L, Harrington RA, Bhatt DL. Reduced immediate ischemic events with cangrelor in PCI: a pooled analysis of the CHAMPION trials using the universal definition of myocardial infarction. Am Heart J. 2012 Feb;163(2):182-90.e4. doi: 10.1016/j.ahj.2011.11.001.

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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.

Simona Skerjanec, PharmD study director

The Medicines Company

Deepak L. Bhatt, MD principal investigator

The Cleveland Clinic

Robert A. Harrington, MD principal investigator

Duke University

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cangrelor and clopidogrel in people with Atherosclerosis and Acute Coronary Syndrome (ACS), run by The Medicines Company at 1 site in United States.

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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 5 May 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 21 Apr 2014). 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?

Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) (time frame: randomization through 48 hours post 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 NCT00385138, which also lists 8 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 5 May 2014; AzTrials last refreshed its copy on 26 Oct 2026.