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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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 ]
- Index of Microvascular Resistance (IMR) measurement using pressure wire studies immediately following the PPCI procedure. [ Time Frame: 1 hour ]
- Measurement of thrombolysis in myocardial infarction (TIMI) flow grade using TIMI Frame Count [ Time Frame: 3 Months ]
- ST Segment Resolution by ECG [ Time Frame: 90-120 minutes post PPCI ]
- Infarct size by Peak Troponin post PPCI [ Time Frame: 24-36 hours ]
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
|The Royal Wolverhampton NHS Trust|
|Wolverhampton, United Kingdom, WV10 0QP|
|Principal Investigator:||James Cotton||The Royal Wolverhampton NHS Trust|