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Trial record 14 of 27 for:    cangrelor

The Effect of IV Cangrelor and Oral Ticagrelor Study

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ClinicalTrials.gov Identifier: NCT02733341
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome (ACS) High On-treatment Platelet Reactivity (HTPR) Microvascular Obstruction (MVO) ST-segment Elevation Myocardial Infarction (STEMI) Thrombolysis in Myocardial Infarction (TIMI) Unstable Angina (UA) Drug: Cangrelor Drug: Ticagrelor Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 21, 2016
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733341


Locations
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United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Investigators
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Principal Investigator: James Cotton The Royal Wolverhampton NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02733341     History of Changes
Other Study ID Numbers: 2015CAR77
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Royal Wolverhampton Hospitals NHS Trust:
Cangrelor
Adenosine Diphosphate
Cardiovascular Magnetic Resonance (CMR)
Index of microvascular resistance (IMR)
Vasodilator stimulated phosphoprotein phosphorylation (VASP)
Pharmacodynamic
Antiplatelet
Myocardial Infarction (MI)
Ticagrelor
Coronary artery bypass graft (CABG)
Primary percutaneous coronary intervention (PPCI)
Additional relevant MeSH terms:
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Cangrelor
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs