Trial Outcomes & Findings for The Effect of IV Cangrelor and Oral Ticagrelor Study (NCT NCT02733341)

Results Overview

P2Y12 inhibition was measured using VerifyNow™ rapid platelet function analyzer at the time of infarct vessel balloon inflation, 4 hours following study drug loading and at 24-36 hours. A single value was calculated by using the mean/average value. Results are expressed as P2Y12 reaction units (PRU), indicating the degree of ADP- mediated aggregation specific to the P2Y12 receptor. PRU values of ≥208 are indicative of a suboptimal response and are associated with poor clinical outcomes including death, MI and stroke at one year.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

Measured at 4, 24 and 36 hours post dosing

Results posted on

2025-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	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. Ticagrelor	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 Cangrelor
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Ticagrelor n=50 Participants 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. Ticagrelor	Intravenous Cangrelor n=50 Participants 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 Cangrelor	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=50 Participants	27 Participants n=50 Participants	58 Participants n=100 Participants
Age, Categorical >=65 years	19 Participants n=50 Participants	23 Participants n=50 Participants	42 Participants n=100 Participants
Age, Continuous	63.4 years STANDARD_DEVIATION 12.9 • n=50 Participants	61.2 years STANDARD_DEVIATION 13.9 • n=50 Participants	62.3 years STANDARD_DEVIATION 13.2 • n=100 Participants
Sex: Female, Male Female	17 Participants n=50 Participants	11 Participants n=50 Participants	28 Participants n=100 Participants
Sex: Female, Male Male	33 Participants n=50 Participants	39 Participants n=50 Participants	72 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants

PRIMARY outcome

Timeframe: Measured at 4, 24 and 36 hours post dosing

P2Y12 inhibition was measured using VerifyNow™ rapid platelet function analyzer at the time of infarct vessel balloon inflation, 4 hours following study drug loading and at 24-36 hours. A single value was calculated by using the mean/average value. Results are expressed as P2Y12 reaction units (PRU), indicating the degree of ADP- mediated aggregation specific to the P2Y12 receptor. PRU values of ≥208 are indicative of a suboptimal response and are associated with poor clinical outcomes including death, MI and stroke at one year.

Outcome measures

Outcome measures
Measure	Oral Ticagrelor n=50 Participants 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. Ticagrelor	Intravenous Cangrelor n=50 Participants 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 Cangrelor
Degree of Platelet Inhibition Measured	248.3 Platelet Reactivity Units (PRU) Standard Deviation 55.1	145.2 Platelet Reactivity Units (PRU) Standard Deviation 50.6

SECONDARY outcome

Timeframe: 1 hour

Index of Microvascular Resistance (IMR) measurement using pressure wire studies immediately following the PPCI procedure. At the end of the clinical procedure a coronary pressure-/ temperature-sensitive guidewire (Radi Medical Systems, Uppsala, Sweden) will be utilised. The guidewire will be calibrated outside the body then equalized within the guide catheter, with the pressure sensor positioned at the ostium of the guide catheter. The guidewire microsensor will be advanced into the distal third of the culprit artery. The apparent IMR is calculated by multiplying the distal coronary pressure by the mean transit time of a 3 ml bolus of saline at room temperature during coronary hyperaemia induced by intravenous adenosine.

Outcome measures

Outcome measures
Measure	Oral Ticagrelor n=50 Participants 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. Ticagrelor	Intravenous Cangrelor n=50 Participants 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 Cangrelor
Index of Microvascular Resistance (IMR) Measurement	131.2 mmHg*seconds Standard Deviation 92.9	158.1 mmHg*seconds Standard Deviation 92.1

SECONDARY outcome

Timeframe: 3 Months

Measurement of thrombolysis in myocardial infarction (TIMI) flow grade using TIMI Frame Count. The TFC is a simple, reproducible, objective, and quantitative index of coronary flow that allows standardization of TIMI flow grades and facilitates comparisons of angiographic end points between trials.

Outcome measures

Outcome measures
Measure	Oral Ticagrelor n=50 Participants 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. Ticagrelor	Intravenous Cangrelor n=50 Participants 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 Cangrelor
Measurement of Thrombolysis in Myocardial Infarction (TIMI)	60.1 frames per second Standard Deviation 56.3	61.0 frames per second Standard Deviation 50.0

SECONDARY outcome

Timeframe: 90-120 minutes post PPCI

ST Segment Resolution by ECG at 90-120 minutes post PPCI A 12 lead EKG was recorded before coronary reperfusion and 90-120 minutes following PPCI to assess ST-segment resolution (STR). This variable was expressed as complete (\>70%), incomplete (\>30% to \< 70%) or none (\<30%).

Outcome measures

Outcome measures
Measure	Oral Ticagrelor n=50 Participants 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. Ticagrelor	Intravenous Cangrelor n=50 Participants 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 Cangrelor
ST Segment Resolution by ECG Complete	36 Participants	32 Participants
ST Segment Resolution by ECG Partial	7 Participants	11 Participants
ST Segment Resolution by ECG None	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 24-36 hours

High sensitivity cardiac troponin T (cTnT) was measured at 24-36 hours following PPCI A blood sample will be taken 24-36 hours post PPCI to determine peak high sensitivity troponin levels.

Outcome measures

Outcome measures
Measure	Oral Ticagrelor n=50 Participants 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. Ticagrelor	Intravenous Cangrelor n=50 Participants 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 Cangrelor
The Impact of Cangrelor vs Ticagrelor on Initial Myocardial Infarct Size Based on Peak Troponin	55 nanograms per liter Interval 44.5 to 61.5	56.50 nanograms per liter Interval 47.5 to 59.25

Adverse Events

Oral Ticagrelor

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Intravenous Cangrelor

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Ticagrelor n=50 participants at risk 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. Ticagrelor	Intravenous Cangrelor n=50 participants at risk 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 Cangrelor
Cardiac disorders Acute Pulmonary Oedema	0.00% 0/50 • 1 year All serious adverse events will be reported. Depending on the nature of the event the reporting procedures will be followed. Any questions concerning serious adverse events reporting will be directed to the Chief Investigator in the first instance. All serious adverse events will be reported to the appropriate regulatory and ethical authorities.	2.0% 1/50 • Number of events 1 • 1 year All serious adverse events will be reported. Depending on the nature of the event the reporting procedures will be followed. Any questions concerning serious adverse events reporting will be directed to the Chief Investigator in the first instance. All serious adverse events will be reported to the appropriate regulatory and ethical authorities.

Other adverse events

Other adverse events
Measure	Oral Ticagrelor n=50 participants at risk 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. Ticagrelor	Intravenous Cangrelor n=50 participants at risk 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 Cangrelor
Blood and lymphatic system disorders Hematoma	6.0% 3/50 • 1 year All serious adverse events will be reported. Depending on the nature of the event the reporting procedures will be followed. Any questions concerning serious adverse events reporting will be directed to the Chief Investigator in the first instance. All serious adverse events will be reported to the appropriate regulatory and ethical authorities.	4.0% 2/50 • 1 year All serious adverse events will be reported. Depending on the nature of the event the reporting procedures will be followed. Any questions concerning serious adverse events reporting will be directed to the Chief Investigator in the first instance. All serious adverse events will be reported to the appropriate regulatory and ethical authorities.
Respiratory, thoracic and mediastinal disorders Shortness of breath	2.0% 1/50 • 1 year All serious adverse events will be reported. Depending on the nature of the event the reporting procedures will be followed. Any questions concerning serious adverse events reporting will be directed to the Chief Investigator in the first instance. All serious adverse events will be reported to the appropriate regulatory and ethical authorities.	0.00% 0/50 • 1 year All serious adverse events will be reported. Depending on the nature of the event the reporting procedures will be followed. Any questions concerning serious adverse events reporting will be directed to the Chief Investigator in the first instance. All serious adverse events will be reported to the appropriate regulatory and ethical authorities.

Additional Information

Professor James Cotton

The Royal Wolverhampton NHS Trust

Phone: 01902307999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place