The Effect of IV Cangrelor and Oral Ticagrelor Study

Acute Coronary Syndrome (ACS) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733341
• Other study ID #: 2015CAR77
• Status: Completed
• Phase: Phase 4
• Start date: July 21, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: The Royal Wolverhampton Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Angina, Unstable
• High On-treatment Platelet Reactivity (HTPR)
• Infarction
• Microvascular Obstruction (MVO)
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)
• Thrombolysis in Myocardial Infarction (TIMI)
• Unstable Angina (UA)

Intervention

Drug:
• Cangrelor

• Ticagrelor

Locations

Country	Name	City	State
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Wolverhampton Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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