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TerminatedNCT00385138PlatformUpdated May 5, 2014Results posted

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

A Phase 3 interventional study of Cangrelor and clopidogrel in Atherosclerosis and Acute Coronary Syndrome (ACS), sponsored by The Medicines Company. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-05.

Sponsored by The Medicines Company · Phase 3, Interventional, and Treatment

Why this study was terminated
Insufficient evidence of the clinical effectiveness of cangrelor
Phase
Phase 3
Study type
Interventional
Enrollment
5,364
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 revascularization (IDR).

02

Conditions studied

  • Atherosclerosis
  • Acute Coronary Syndrome (ACS)

Keywords

  • Percutaneous Coronary Intervention (PCI)
  • ACS
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 5,364 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

The Medicines Company is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  1. Not a candidate for PCI
  2. ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization
  3. 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
  4. 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
  5. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
  6. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
  7. Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization
  8. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients]
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
5,364 participants (actual)

Study arms

  • Experimental
    Cangrelor

    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

    Drug: Cangrelor · Drug: clopidogrel · Drug: Placebo capsules - end of PCI

  • Active comparator
    Clopidogrel

    placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion

    Drug: clopidogrel · Drug: Placebo bolus & placebo infusion · Drug: Placebo capsules - end of infusion

Interventions

  • DrugCangrelor

    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)

  • Drugclopidogrel

    clopidogrel capsules (600 mg) at end of PCI

    Also known as: Plavix

  • DrugPlacebo bolus & placebo infusion

    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)

  • DrugPlacebo capsules - end of PCI

    Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing

  • DrugPlacebo capsules - end of infusion

    Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing

06

What researchers measure

Primary outcomes

  1. Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)

    mITT population; (composite incidence)

    Time frame: randomization through 48 hours post randomization

Secondary outcomes

  1. Incidence of All-cause Mortality or MI

    mITT population

    Time frame: randomization through 48 hours post randomization

  2. Incidence of All-cause Mortality

    mITT population

    Time frame: randomization through 48 hours post randomization

  3. Incidence of MI

    mITT population

    Time frame: randomization through 48 hours post randomization

  4. Incidence of IDR

    mITT population

    Time frame: randomization through 48 hours post randomization

  5. Incidence of Stent Thrombosis

    mITT population

    Time frame: randomization through 48 hours post randomization

  6. Incidence of Stroke

    mITT

    Time frame: randomization through 48 hours post randomization

  7. Incidence of All-cause Mortality

    mITT population

    Time frame: randomization through 1 year post randomization

  8. 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.

    Time frame: During index PCI

  9. Incidence of GUSTO Severe / Life-threatening

    Major bleeding (non-CABG-related) - Safety population

    Time frame: randomization through 48 hours post randomization

  10. Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major

    Major bleeding (non-CABG-related) - Safety population

    Time frame: randomization through 48 hours post randomization

  11. Incidence of ACUITY Major Bleeding

    Major bleeding (non-CABG-related) - Safety population

    Time frame: randomization through 48 hours post randomization

  12. 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.

    Time frame: randomization through 48 hours post randomization

  13. Incidence of All-cause Mortality, MI, or IDR

    mITT population

    Time frame: randomization through 30 days post randomization

  14. Incidence of All-cause Mortality or MI

    mITT population

    Time frame: randomization through 30 days post randomization

  15. Incidence of All-cause Mortality

    mITT population

    Time frame: randomization through 30 days post randomization

  16. Incidence of MI

    mITT population

    Time frame: randomization through 30 days post randomization

  17. Incidence of IDR

    mITT population

    Time frame: randomization through 30 days post randomization

  18. Incidence of Stent Thrombosis

    mITT population

    Time frame: randomization through 30 days post randomization

  19. Incidence of Stroke

    mITT population

    Time frame: randomization through 30 days post randomization

07

Results

Posted Apr 21, 2014
Limitations and caveats
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.

Participant flow

Patients were selected for randomization based on the need for percutaneous coronary intervention (PCI). Randomization could only occur after the need for PCI was confirm by angiography.

Participant flow — Overall Study
MilestoneCangrelorClopidogrel
Started26952669
Intent-to-treat (itt)26932669
Modified intent-to-treat (mitt)26562645
Safety population26622650
Completed26652641
Not completed3028

Outcome measures

PrimaryIncidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)

mITT population; (composite incidence)

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
participantsCangrelorClopidogrel
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)185210
SecondaryIncidence of All-cause Mortality or MI

mITT population

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of All-cause Mortality or MI
participantsCangrelorClopidogrel
Incidence of All-cause Mortality or MI180204
SecondaryIncidence of All-cause Mortality

mITT population

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of All-cause Mortality
participantsCangrelorClopidogrel
Incidence of All-cause Mortality618
SecondaryIncidence of MI

mITT population

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of MI
participantsCangrelorClopidogrel
Incidence of MI177191
SecondaryIncidence of IDR

mITT population

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of IDR
participantsCangrelorClopidogrel
Incidence of IDR1924
SecondaryIncidence of Stent Thrombosis

mITT population

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of Stent Thrombosis
participantsCangrelorClopidogrel
Incidence of Stent Thrombosis516
SecondaryIncidence of Stroke

mITT

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of Stroke
participantsCangrelorClopidogrel
Incidence of Stroke75
SecondaryIncidence of All-cause Mortality

mITT population

Time frame:
randomization through 1 year post randomization
Reported as:
Number · participants
Incidence of All-cause Mortality
participantsCangrelorClopidogrel
Incidence of All-cause Mortality94113
SecondaryIncidence 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.

Time frame:
During index PCI
Reported as:
Number · participants
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]
participantsCangrelorClopidogrel
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]122142
SecondaryIncidence of GUSTO Severe / Life-threatening

Major bleeding (non-CABG-related) - Safety population

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of GUSTO Severe / Life-threatening
participantsCangrelorClopidogrel
Incidence of GUSTO Severe / Life-threatening96
SecondaryIncidence of Thrombolysis in Myocardial Infarction (TIMI) Major

Major bleeding (non-CABG-related) - Safety population

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
participantsCangrelorClopidogrel
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major49
SecondaryIncidence of ACUITY Major Bleeding

Major bleeding (non-CABG-related) - Safety population

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of ACUITY Major Bleeding
participantsCangrelorClopidogrel
Incidence of ACUITY Major Bleeding14591
SecondaryIncidence 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.

Time frame:
randomization through 48 hours post randomization
Reported as:
Number · participants
Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
participantsCangrelorClopidogrel
Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm4329
SecondaryIncidence of All-cause Mortality, MI, or IDR

mITT population

Time frame:
randomization through 30 days post randomization
Reported as:
Number · participants
Incidence of All-cause Mortality, MI, or IDR
participantsCangrelorClopidogrel
Incidence of All-cause Mortality, MI, or IDR227249
SecondaryIncidence of All-cause Mortality or MI

mITT population

Time frame:
randomization through 30 days post randomization
Reported as:
Number · participants
Incidence of All-cause Mortality or MI
participantsCangrelorClopidogrel
Incidence of All-cause Mortality or MI213233
SecondaryIncidence of All-cause Mortality

mITT population

Time frame:
randomization through 30 days post randomization
Reported as:
Number · participants
Incidence of All-cause Mortality
participantsCangrelorClopidogrel
Incidence of All-cause Mortality3545
SecondaryIncidence of MI

mITT population

Time frame:
randomization through 30 days post randomization
Reported as:
Number · participants
Incidence of MI
participantsCangrelorClopidogrel
Incidence of MI189201
SecondaryIncidence of IDR

mITT population

Time frame:
randomization through 30 days post randomization
Reported as:
Number · participants
Incidence of IDR
participantsCangrelorClopidogrel
Incidence of IDR3746
SecondaryIncidence of Stent Thrombosis

mITT population

Time frame:
randomization through 30 days post randomization
Reported as:
Number · participants
Incidence of Stent Thrombosis
participantsCangrelorClopidogrel
Incidence of Stent Thrombosis1528
SecondaryIncidence of Stroke

mITT population

Time frame:
randomization through 30 days post randomization
Reported as:
Number · participants
Incidence of Stroke
participantsCangrelorClopidogrel
Incidence of Stroke65

Adverse events

Collected over Adverse events were collected through 48 hours after study drug initiation. Non-serious events are listed at a 0.5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cangrelor—48/2,662 (1.8%)596/2,662 (22.4%)
Clopidogrel—55/2,650 (2.1%)530/2,650 (20%)
Most frequent serious events
Showing 10 of 57
Most frequent serious events
EventCangrelorClopidogrel
cardiogenic shockCardiac disorders6/266211/2650
pulmonary oedemaRespiratory, thoracic and mediastinal disorders2/26624/2650
hypotensionVascular disorders1/26624/2650
ventricular fibrillationCardiac disorders4/26622/2650
cardiac arrestCardiac disorders1/26623/2650
electromechanical dissociationCardiac disorders1/26623/2650
cardiac failure congestiveCardiac disorders3/26621/2650
acute pulmonary oedemaRespiratory, thoracic and mediastinal disorders3/26620/2650
coronary artery dissectionCardiac disorders0/26622/2650
torsade de pointesCardiac disorders0/26622/2650
Most frequent other events
Showing 10 of 18
Most frequent other events
EventCangrelorClopidogrel
back painMusculoskeletal and connective tissue disorders91/266285/2650
chest painGeneral disorders73/266269/2650
nauseaGastrointestinal disorders71/266266/2650
headacheNervous system disorders60/266268/2650
hypotensionVascular disorders43/266238/2650
dyspneaRespiratory, thoracic and mediastinal disorders38/266215/2650
vomitingGastrointestinal disorders37/266231/2650
pyrexiaGeneral disorders36/266220/2650
puncture site painGeneral disorders21/266229/2650
hypertensionVascular disorders28/266222/2650

Baseline characteristics

mITT population

Age, Continuous
Age, Continuous(years)CangrelorClopidogrelTotal
Mean62.5 ± 11.462.5 ± 11.362.5 ± 11.4
Sex: Female, Male
Sex: Female, Male(Participants)CangrelorClopidogrelTotal
Female7477821529
Male190918633772
Region of Enrollment
Region of Enrollment(participants)CangrelorClopidogrelTotal
United States8158091624
Argentina394281
Brazil484997
Bulgaria403394797
Canada325
Czech Republic342345687
Georgia474390
India235236471
Lithuania5455109
New Zealand222042
Belarus333164
Russian Federation215218433
Slovakia332760
South Africa102100202
Korea, Republic of159166325
Spain172138
Thailand5858116
Netherlands312960
08

Study locations

1 site
  • Innovis Health
    Fargo, North Dakota 58104, United States
09

References and documents

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 ↗
  • 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. Erratum In: Circ Cardiovasc Interv. 2018 Sep;11(9):e000036. doi: 10.1161/HCV.0000000000000036. Angiolillo, Dominick [corrected to Angiolillo, Dominick J]. 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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00385138
Lead sponsor
The Medicines Company
Responsible party
Sponsor
First posted
Oct 6, 2006
Start date
Sep 2006
Primary completion
May 2009
Completion
Jun 2010
Results posted
Apr 21, 2014
Last update
May 5, 2014

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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