search
Back to results

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

Primary Purpose

Atherosclerosis, Acute Coronary Syndrome (ACS)

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cangrelor
clopidogrel
Placebo bolus & placebo infusion
Placebo capsules - end of PCI
Placebo capsules - end of infusion
Sponsored by
The Medicines Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Percutaneous Coronary Intervention (PCI), ACS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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]

Sites / Locations

  • Innovis Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cangrelor

Clopidogrel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
mITT population; (composite incidence)

Secondary Outcome Measures

Incidence of All-cause Mortality or MI
mITT population
Incidence of All-cause Mortality
mITT population
Incidence of MI
mITT population
Incidence of IDR
mITT population
Incidence of Stent Thrombosis
mITT population
Incidence of Stroke
mITT
Incidence of All-cause Mortality
mITT population
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.
Incidence of GUSTO Severe / Life-threatening
Major bleeding (non-CABG-related) - Safety population
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
Major bleeding (non-CABG-related) - Safety population
Incidence of ACUITY Major Bleeding
Major bleeding (non-CABG-related) - Safety population
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.
Incidence of All-cause Mortality, MI, or IDR
mITT population
Incidence of All-cause Mortality or MI
mITT population
Incidence of All-cause Mortality
mITT population
Incidence of MI
mITT population
Incidence of IDR
mITT population
Incidence of Stent Thrombosis
mITT population
Incidence of Stroke
mITT population

Full Information

First Posted
October 4, 2006
Last Updated
April 18, 2014
Sponsor
The Medicines Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00385138
Brief Title
Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.
Acronym
Platform
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient evidence of the clinical effectiveness of cangrelor
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medicines Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Acute Coronary Syndrome (ACS)
Keywords
Percutaneous Coronary Intervention (PCI), ACS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
5364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cangrelor
Arm Type
Experimental
Arm Description
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
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Intervention Type
Drug
Intervention Name(s)
Cangrelor
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
clopidogrel capsules (600 mg) at end of PCI
Intervention Type
Drug
Intervention Name(s)
Placebo bolus & placebo infusion
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo capsules - end of PCI
Intervention Description
Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing
Intervention Type
Drug
Intervention Name(s)
Placebo capsules - end of infusion
Intervention Description
Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
Primary Outcome Measure Information:
Title
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
Description
mITT population; (composite incidence)
Time Frame
randomization through 48 hours post randomization
Secondary Outcome Measure Information:
Title
Incidence of All-cause Mortality or MI
Description
mITT population
Time Frame
randomization through 48 hours post randomization
Title
Incidence of All-cause Mortality
Description
mITT population
Time Frame
randomization through 48 hours post randomization
Title
Incidence of MI
Description
mITT population
Time Frame
randomization through 48 hours post randomization
Title
Incidence of IDR
Description
mITT population
Time Frame
randomization through 48 hours post randomization
Title
Incidence of Stent Thrombosis
Description
mITT population
Time Frame
randomization through 48 hours post randomization
Title
Incidence of Stroke
Description
mITT
Time Frame
randomization through 48 hours post randomization
Title
Incidence of All-cause Mortality
Description
mITT population
Time Frame
randomization through 1 year post randomization
Title
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]
Description
mITT population A patient could have multiple procedural events.
Time Frame
During index PCI
Title
Incidence of GUSTO Severe / Life-threatening
Description
Major bleeding (non-CABG-related) - Safety population
Time Frame
randomization through 48 hours post randomization
Title
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
Description
Major bleeding (non-CABG-related) - Safety population
Time Frame
randomization through 48 hours post randomization
Title
Incidence of ACUITY Major Bleeding
Description
Major bleeding (non-CABG-related) - Safety population
Time Frame
randomization through 48 hours post randomization
Title
Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
Description
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
Title
Incidence of All-cause Mortality, MI, or IDR
Description
mITT population
Time Frame
randomization through 30 days post randomization
Title
Incidence of All-cause Mortality or MI
Description
mITT population
Time Frame
randomization through 30 days post randomization
Title
Incidence of All-cause Mortality
Description
mITT population
Time Frame
randomization through 30 days post randomization
Title
Incidence of MI
Description
mITT population
Time Frame
randomization through 30 days post randomization
Title
Incidence of IDR
Description
mITT population
Time Frame
randomization through 30 days post randomization
Title
Incidence of Stent Thrombosis
Description
mITT population
Time Frame
randomization through 30 days post randomization
Title
Incidence of Stroke
Description
mITT population
Time Frame
randomization through 30 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Skerjanec, PharmD
Organizational Affiliation
The Medicines Company
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deepak L. Bhatt, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert A. Harrington, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovis Health
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19915222
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.
Results Reference
result
PubMed Identifier
35196863
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.
Results Reference
derived
PubMed Identifier
29632238
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. Erratum In: Circ Cardiovasc Interv. 2018 Sep;11(9):e000036. Angiolillo, Dominick [corrected to Angiolillo, Dominick J].
Results Reference
derived
PubMed Identifier
28988157
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.
Results Reference
derived
PubMed Identifier
28382371
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.
Results Reference
derived
PubMed Identifier
27902833
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.
Results Reference
derived
PubMed Identifier
22305835
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs