Myocardial Infarction (MI)Phase 3PCINCT00305162
A Clinical Trial to Demonstrate the Efficacy of Cangrelor
A Phase 3 study testing Cangrelor (P2Y12 inhibitor) and clopidogrel (oral P2Y12 inhibitor) in people with Myocardial Infarction (MI) and Acute Coronary Syndromes (ACS), run by The Medicines Company at 1 site in United States.
Trial summary
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction (MI), Acute Coronary Syndromes (ACS)
- What is being tested?
- Cangrelor (P2Y12 inhibitor) and clopidogrel (oral P2Y12 inhibitor)
- 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
- 8,882 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 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
- To be included in this study, subjects must meet the following 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 or ST-elevation MI.
Who cannot join
- Subjects will be excluded from the study if they present with any of the following:
- Not a candidate for PCI
- Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including by-pass 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), or history of thrombocytopenia or neutropenia associated with clopidogrel
- Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
- Receipt of fibrinolytic therapy in the 12 hours preceding randomization
Show all 10Show fewer
- Receipt of clopidogrel dose exceeding maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization
- Inability to swallow study capsules
- Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients]
- Subjects excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107-6192
About this study
Official title: A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention (PCI).
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.
- Being tested
- Cangrelor (P2Y12 inhibitor), clopidogrel (oral P2Y12 inhibitor), Placebo bolus & placebo infusion, Placebo capsules - end of infusion, Placebo capsules - as soon as possible after randomization
- Keywords
- Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), non-ST-segment elevation myocardial infarction (NSTEMI), ST-segment elevation myocardial infarction (STEMI)
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cangrelor (P2Y12 inhibitor)Drug
IV bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue 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 (oral P2Y12 inhibitor)Drug
Also called Plavix
600 mg active clopidogrel administered as soon as possible following randomization (after need for PCI confirmed), but not more than 30 minutes prior to the placement of the arterial access.
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 infusionDrug
Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
Placebo capsules - as soon as possible after randomizationDrug
Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing
| Study group | Role | What they receive |
|---|---|---|
| Cangrelor | Experimental | placebo capsules (to match) + 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) + active clopidogrel (600mg) post infusion Receives: Drug: Cangrelor (P2Y12 inhibitor); Drug: clopidogrel (oral P2Y12 inhibitor); Drug: Placebo capsules - as soon as possible after randomization |
| Clopidogrel | Active comparator | clopidogrel capsules (600 mg) + placebo bolus \& infusion (to match) + placebo capsules (to match) post infusion Receives: Drug: clopidogrel (oral P2Y12 inhibitor); 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)
(composite incidence)
Measured: randomization through 48 hours after randomization
Secondary outcomes (16)
Incidence of All-cause Mortality and MI
(composite incidence)
Measured: randomization through 48 hours after randomization
Individual Incidence of All-cause Mortality
Measured: randomization through 48 hours after randomization
Individual Incidence of IDR
Measured: randomization through 48 hours after randomization
Incidence of Stroke
Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:
- primary hemorrhagic - stroke with focal collections of intracranial blood
- ischemic cerebral infarction - stroke without focal collections of intracranial blood
- infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding
- uncertain - no imaging or autopsy data are available.
Measured: randomization through 48 hours after randomization
Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI
(a patient could have multiple procedural events)
Measured: during index PCI
Incidence of All-cause Mortality, MI or IDR
(composite incidence)
Measured: randomization through 30 days after randomization
Incidence of All-cause Mortality or MI
(composite incidence)
Measured: randomization through 30 days after randomization
Incidence of All-cause Mortality
Measured: randomization through 30 days after randomization
Incidence of MI
Measured: randomization through 30 days after randomization
Incidence of IDR
Measured: randomization through 30 days after randomization
Incidence of Stroke
Measured: randomization through 30 days after randomization
Incidence of All Cause Mortality
(excluding STEMI)
Measured: randomization through 1 year after randomization
Incidence of GUSTO Severe / Life-threatening Bleeding
Major bleeding (non-CABG-related) - Safety population
Measured: randomization through 48 hours after randomization
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Major bleeding (non-CABG-related) - Safety population
Measured: randomization through 48 hours after randomization
Incidence of ACUITY Major Bleeding
Major bleeding (non-CABG-related) - Safety population
Measured: randomization through 48 hours after randomization
Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)
excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm
Measured: randomization through 48 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startApr 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 Myocardial Infarction (MI)Studies 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
- 8,882 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepak L. Bhatt, MD, Principal investigator, The Cleveland ClinicRobert A. Harrington, MD, Principal investigator, Duke University Medical Center and Duke Clinical Research InstituteSimona Skerjanec, PharmD, Study director, The Medicines Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305162
- Sponsor's protocol ID
- TMC-CAN-05-02
- Acronym
- PCI
- Status last verified
- Apr 2014
- First submitted
- 17 Mar 2006
- Last updated
- 8 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harrington RA, Stone GW, McNulty S, White HD, Lincoff AM, Gibson CM, Pollack CV Jr, Montalescot G, Mahaffey KW, Kleiman NS, Goodman SG, Amine M, Angiolillo DJ, Becker RC, Chew DP, French WJ, Leisch F, Parikh KH, Skerjanec S, Bhatt DL. Platelet inhibition with cangrelor in patients undergoing PCI. N Engl J Med. 2009 Dec 10;361(24):2318-29. doi: 10.1056/NEJMoa0908628.
PubMed 19915221Gutierrez 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 38551015Peterson 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 35196863Groves 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 29632238Vaduganathan 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 28988157Parker 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 28382371Vaduganathan 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 27902833White 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention (PCI).
- ClinicalTrials.gov ID
- NCT00305162
- Acronym / sponsor ID
- PCI / TMC-CAN-05-02
- Keywords
- Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), non-ST-segment elevation myocardial infarction (NSTEMI), ST-segment elevation myocardial infarction (STEMI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient evidence of the clinical effectiveness of cangrelor
- Enrolment
- 8,882 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Mar 2006 (estimated)
- Results
- Posted 23 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.
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 (P2Y12 inhibitor), Drug: clopidogrel (oral P2Y12 inhibitor), Drug: Placebo capsules - as soon as possible after randomizationplacebo capsules (to match) + 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) + active clopidogrel (600mg) post infusion |
| Clopidogrel | Active comparator | Drug: clopidogrel (oral P2Y12 inhibitor), Drug: Placebo bolus & placebo infusion, Drug: Placebo capsules - end of infusionclopidogrel capsules (600 mg) + placebo bolus \& infusion (to match) + placebo capsules (to match) post infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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 or ST-elevation MI.
Key exclusion criteria (10 listed)
- Not a candidate for PCI
- Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including by-pass 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), or history of thrombocytopenia or neutropenia associated with clopidogrel
- Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
- Receipt of fibrinolytic therapy in the 12 hours preceding 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 |
|---|---|---|
| Cangrelor (P2Y12 inhibitor)IV bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue 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 |
| clopidogrel (oral P2Y12 inhibitor)Also: Plavix600 mg active clopidogrel administered as soon as possible following randomization (after need for PCI confirmed), but not more than 30 minutes prior to the placement of the arterial access. | 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 infusionPlacebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing | Drug | Clopidogrel |
| Placebo capsules - as soon as possible after randomizationPlacebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing | Drug | Cangrelor |
Primary outcome
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
Time frame: randomization through 48 hours after randomization
(composite incidence)
16 secondary outcomes
Incidence of All-cause Mortality and MI
Time frame: randomization through 48 hours after randomization
Individual Incidence of All-cause Mortality
Time frame: randomization through 48 hours after randomization
Individual Incidence of IDR
Time frame: randomization through 48 hours after randomization
Incidence of Stroke
Time frame: randomization through 48 hours after randomization
Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI
Time frame: during index PCI
Incidence of All-cause Mortality, MI or IDR
Time frame: randomization through 30 days after randomization
Incidence of All-cause Mortality or MI
Time frame: randomization through 30 days after randomization
Incidence of All-cause Mortality
Time frame: randomization through 30 days after randomization
Incidence of MI
Time frame: randomization through 30 days after randomization
Incidence of IDR
Time frame: randomization through 30 days after randomization
Incidence of Stroke
Time frame: randomization through 30 days after randomization
Incidence of All Cause Mortality
Time frame: randomization through 1 year after randomization
Incidence of GUSTO Severe / Life-threatening Bleeding
Time frame: randomization through 48 hours after randomization
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Time frame: randomization through 48 hours after randomization
Incidence of ACUITY Major Bleeding
Time frame: randomization through 48 hours after randomization
Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)
Time frame: randomization through 48 hours after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19915221Harrington RA, Stone GW, McNulty S, White HD, Lincoff AM, Gibson CM, Pollack CV Jr, Montalescot G, Mahaffey KW, Kleiman NS, Goodman SG, Amine M, Angiolillo DJ, Becker RC, Chew DP, French WJ, Leisch F, Parikh KH, Skerjanec S, Bhatt DL. Platelet inhibition with cangrelor in patients undergoing PCI. N Engl J Med. 2009 Dec 10;361(24):2318-29. doi: 10.1056/NEJMoa0908628.
- 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.
Deepak L. Bhatt, MD principal investigator
The Cleveland Clinic
Robert A. Harrington, MD principal investigator
Duke University Medical Center and Duke Clinical Research Institute
Simona Skerjanec, PharmD study director
The Medicines Company
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 (P2Y12 inhibitor) and clopidogrel (oral P2Y12 inhibitor) in people with Myocardial Infarction (MI) and Acute Coronary Syndromes (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 2 inclusion and 10 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 8 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 23 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 after 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 NCT00305162, 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 8 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.