Clinical trial NCT00385138: Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.
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).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atherosclerosis
Acute Coronary Syndrome (ACS)
Keywords: Percutaneous Coronary Intervention (PCI)
ACS
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 5364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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:

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

Primary outcomes:
measure: Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
timeFrame: randomization through 48 hours post randomization
Secondary outcomes:
measure: Incidence of All-cause Mortality or MI
timeFrame: randomization through 48 hours post randomization
measure: Incidence of All-cause Mortality
timeFrame: randomization through 48 hours post randomization
measure: Incidence of MI
timeFrame: randomization through 48 hours post randomization
measure: Incidence of IDR
timeFrame: randomization through 48 hours post randomization
measure: Incidence of Stent Thrombosis
timeFrame: randomization through 48 hours post randomization
measure: Incidence of Stroke
timeFrame: randomization through 48 hours post randomization
measure: Incidence of All-cause Mortality
timeFrame: randomization through 1 year post randomization
measure: 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]
timeFrame: During index PCI
measure: Incidence of GUSTO Severe / Life-threatening
timeFrame: randomization through 48 hours post randomization
measure: Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
timeFrame: randomization through 48 hours post randomization
measure: Incidence of ACUITY Major Bleeding
timeFrame: randomization through 48 hours post randomization
measure: Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
timeFrame: randomization through 48 hours post randomization
measure: Incidence of All-cause Mortality, MI, or IDR
timeFrame: randomization through 30 days post randomization
measure: Incidence of All-cause Mortality or MI
timeFrame: randomization through 30 days post randomization
measure: Incidence of All-cause Mortality
timeFrame: randomization through 30 days post randomization
measure: Incidence of MI
timeFrame: randomization through 30 days post randomization
measure: Incidence of IDR
timeFrame: randomization through 30 days post randomization
measure: Incidence of Stent Thrombosis
timeFrame: randomization through 30 days post randomization
measure: Incidence of Stroke
timeFrame: randomization through 30 days post randomization
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Innovis Health
state: North Dakota
Study officials:
affiliation: The Medicines Company
name: Simona Skerjanec, PharmD
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Deepak L. Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Robert A. Harrington, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.