The Effect of IV Cangrelor and Oral Ticagrelor Study

October 29, 2018 updated by: The Royal Wolverhampton Hospitals NHS Trust

The Effect of Intravenous Cangrelor and Oral Ticagrelor on Platelets, the Microcirculation and Myocardial Damage in Patients Admitted With STEMI Treated by Primary Percutaneous Coronary Intervention: A Randomized Controlled Pilot Trial

Major heart attacks are caused by a number of factors, the two major of which are furring up of a coronary artery with atheroma and then sudden clot formation on this area leading to a blockage and interruption of blood flow. The clots that lead to heart attacks are largely made of clotting blood cells (platelets) that in health repair blood vessels and inhibit spontaneous bleeding. One of the main treatment strategies for heart attacks is to make these cells less "sticky". Aspirin is a main stay of anti-platelet treatment in the United Kingdom (UK) and in addition one of three other oral antiplatelet agents acting on the same platelet activation pathway (P2Y12 receptor) is licensed for use. When a patient is admitted with a major heart attack, they are treated with emergency primary percutaneous coronary intervention (PPCI) a technique where a wire and balloon are used to reopen the coronary artery and then usually a stent (a slotted metal tube) is placed to keep the artery open. Aspirin and one of the P2Y12 inhibitor agents are given to prevent further clots and all have been shown to reduce negative events following heart attacks and angioplasty with stent insertion. There are increasing data, including from our own institution, showing that in the setting of heart attacks, the oral P2Y12 inhibitors are poorly absorbed and have little effect at the time of most need, i.e. soon after dosing while the primary PCI is being performed.

All three current P2Y12 inhibitor agents are taken in tablet form immediately before the emergency PPCI procedure. It appears that in healthy stable patients these agents take at least 30 min to 2 hours to have an adequate effect. In heart attack patients the angioplasty procedure is usually performed well within this timescale. Furthermore, patients who are having a heart attack do not have normal drug absorption with blood being diverted away from the stomach and gut activity being suppressed by other drugs such as morphine.

In this current study, patients with major heart attacks will be given our standard oral agent, Ticagrelor, or the newer intravenous agent Cangrelor prior to PPCI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting with STEMI eligible for PPCI
  • Able to give verbal assent pre procedure and written consent following the procedure.
  • Age ≥18 years
  • No contraindication to Cangrelor or Ticagrelor
  • Thienopyridine naïve

If a patient gives verbal assent but is unable to provide a written consent at a later stage due to incapacitation, presumed consent will be continued. The reasons why a patient becomes incapacitated and becomes unable to provide a written consent will be recorded during data collection.

Exclusion Criteria:

  • Be unable to provide verbal assent and written consent
  • Allergic to Aspirin or any of the P2Y12 antagonists in the trial
  • Have pre-existing cardiogenic shock
  • Previous myocardial infarction
  • Have a concurrent septic or inflammatory disease e.g. rheumatoid arthritis, lupus, and pneumonia.
  • Already taking a P2Y12 inhibitor
  • Known bleeding diathesis
  • Significant active bleeding
  • History of intracranial hemorrhage
  • Patients who are being treated with formal anticoagulation (Vitamin K antagonist, Factor II or Xa inhibitors) or have an indication for anticoagulation during the first four hours of the study period. Example is patients known to have atrial fibrillation, pulmonary embolism or deep vein thrombosis.
  • Known severe renal dysfunction requiring renal replacement therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral Ticagrelor
Patients in the oral Ticagrelor arm will receive Ticagrelor at a loading dose of 180mg followed by maintenance dose of 90mg twice daily for 12 months.
Drug: Ticagrelor
Active Comparator: Intravenous Cangrelor
Patients in the intravenous Cangrelor arm will receive Cangrelor as an initial bolus dose given as per body weight followed by an intravenous infusion for no longer than three hours, they will then switch to oral Ticagrelor given at maintenance dose of 90mg twice daily for 12 months
Drug: Cangrelor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of platelet inhibition measured with VerifyNow(R) system, rapid platelet function analyser and also VASP flow cytometry at infarct vessel open time (also known as balloon time)
Time Frame: up to 24-36 hours post dosing
up to 24-36 hours post dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Index of Microvascular Resistance (IMR) measurement using pressure wire studies immediately following the PPCI procedure.
Time Frame: 1 hour
1 hour
Measurement of thrombolysis in myocardial infarction (TIMI) flow grade using TIMI Frame Count
Time Frame: 3 Months
3 Months
ST Segment Resolution by ECG
Time Frame: 90-120 minutes post PPCI
90-120 minutes post PPCI
Infarct size by Peak Troponin post PPCI
Time Frame: 24-36 hours
24-36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 8, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015CAR77

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST-segment Elevation Myocardial Infarction (STEMI)

Clinical Trials on Ticagrelor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe