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

NCT00385138 | Terminated Phase 3 Results DMC

• 1 other identifier: TMC-CAN-05-03
• Study Type: interventional
• Target: 5,364
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atherosclerosis; Acute Coronary Syndrome (ACS)

Keywords

Percutaneous Coronary Intervention (PCI); ACS

Outcome Measures

Primary Outcomes (1)

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

  mITT population; (composite incidence)

  randomization through 48 hours post randomization

Secondary Outcomes (19)

• Incidence of All-cause Mortality or MI

  randomization through 48 hours post randomization

• Incidence of All-cause Mortality

  randomization through 48 hours post randomization

• Incidence of MI

  randomization through 48 hours post randomization

• Incidence of IDR

  randomization through 48 hours post randomization

• Incidence of Stent Thrombosis

  randomization through 48 hours post randomization

Study Arms (2)

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

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

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

Interventions

Cangrelor DRUG

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)

Cangrelor

clopidogrel DRUG

clopidogrel capsules (600 mg) at end of PCI

Also known as: Plavix

Cangrelor; Clopidogrel

Placebo bolus & placebo infusion DRUG

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)

Clopidogrel

Placebo capsules - end of PCI DRUG

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

Cangrelor

Placebo capsules - end of infusion DRUG

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

Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients\]

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

Innovis Health

Fargo, North Dakota, 58104, United States

Location

Related Publications (8)

• 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.

  PMID: 19915222 RESULT

• 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.

  PMID: 38551015 DERIVED

• 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.

  PMID: 35196863 DERIVED

• 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.

  PMID: 29632238 DERIVED

• 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.

  PMID: 28988157 DERIVED

• 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.

  PMID: 28382371 DERIVED

• 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.

  PMID: 27902833 DERIVED

• 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.

  PMID: 22305835 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Acute Coronary Syndrome

Interventions

cangrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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.

Results Point of Contact

• Title: Meredith Todd
• Organization: The Medicines Company

meredith.todd@themedco.com

973.290.6088

Study Officials

• Simona Skerjanec, PharmD

  The Medicines Company

  STUDY DIRECTOR

• Deepak L. Bhatt, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Robert A. Harrington, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: September 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2010
• Last Updated: May 5, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-04

Locations

US (1)