NCT02943369

Brief Summary

Platelets and thrombus formation play a key role in the pathogenesis of acute coronary artery occlusion and subsequent myocardial infarction. Apart from mechanically opening the occluded artery with angioplasty, adjunctive antiplatelet treatment is of utmost importance. However, orally administered antiplatelet agents exhibit a delay in their onset of action in the setting of acute myocardial infarction and angioplasty is mostly performed without adequate platelet inhibition. Cangrelor is an intravenous antiplatelet agent which can provide almost immediate strong platelet inhibition. The investigators aim to compare a strategy of cangrelor administered on top of ticagrelor-an oral antiplatelet agent- vs ticagrelor alone, on their efficacy to inhibit platelet function in the early hours of an acute myocardial infarction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

July 28, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2017

Completed
Last Updated

December 27, 2017

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

October 21, 2016

Last Update Submit

December 26, 2017

Conditions

STEMI

Keywords

cangrelorticagrelorP2Y12 receptor antagonistacute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Platelet reactivity between the 2 arms

    Platelet reactivity in P2Y12 reaction units by VerifyNow assay

    15 min

Secondary Outcomes (7)

  • Platelet reactivity between the 2 arms

    1 hour

  • Platelet reactivity between the 2 arms

    2 hours

  • Platelet reactivity between the 2 arms

    4 hours

  • High on treatment platelet reactivity rate

    15 min

  • High on treatment platelet reactivity rate

    1 hour

  • +2 more secondary outcomes

Other Outcomes (3)

  • major adverse cardiac events (death, myocardial infarction, stroke, ischemia driven revascularization)

    30 days

  • Bleeding events (BARC classification)

    30 days

  • Other adverse events

    30 days

Study Arms (2)

Cangrelor

EXPERIMENTAL

Ticagrelor will be followed by Cangrelor

Drug: Ticagrelor 180 mg loading doseDrug: Cangrelor 30 mcg/kg bolus + 4 mcg/kg/min

Ticagrelor

ACTIVE COMPARATOR

Ticagrelor only

Drug: Ticagrelor 180 mg loading dose

Interventions

Ticagrelor 180 mg loading doseDRUG

Ticagrelor 180 mg

Also known as: Ticagrelor 180 mg
CangrelorTicagrelor
Cangrelor 30 mcg/kg bolus + 4 mcg/kg/minDRUG

Intravenous Cangrelor 30 mcg/kg bolus + 4 mcg/kg/min for 2 hours

Also known as: Cangrelor bolus and infusion
Cangrelor

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive P2Y12 inhibitor-naive STEMI patients with pain onset\<12 hours admitted for primary PCI.

You may not qualify if:

  • a history of stroke/transient ischemic attack
  • bleeding diathesis
  • chronic oral anticoagulation treatment
  • contraindications to anti platelet therapy
  • PCI or coronary artery bypass grafting \<3 months
  • platelet count \<100 000/μL
  • hematocrit \<30%
  • creatinine clearance \<30 mL/min
  • severe hepatic dysfunction
  • use of strong CYP3A inhibitors or inducers
  • increased risk of bradycardia
  • severe chronic obstructive pulmonary disease
  • periprocedural IIb/IIIa inhibitor administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attikon University Hospital

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ticagrelorcangrelor

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Dimitrios Alexopoulos, MD

    Attikon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology, National and Capodestrian University of Athens

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

July 28, 2017

Primary Completion

November 26, 2017

Study Completion

December 26, 2017

Last Updated

December 27, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)