Trial Outcomes & Findings for Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study) (NCT NCT01612884)

Last Updated: 2018-04-26

Results Overview

Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

67 participants

Primary outcome timeframe

1 day

Results posted on

2018-04-26

Participant Flow

67 subjects were enrolled and underwent testing on day 0. Only 37 of those subjects underwent PCI, and therefore were randomized to either LTA or TEG guided intervention arm. The remainder of subjects were treated medically without PCI or were referred for CABG (see flow diagram in protocol) and did not get randomized to any intervention arm.

Participant milestones

Participant milestones
Measure	Thrombelastography (TEG) Guided Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69 Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder	Light Transmittance Aggregometry Guided Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9% Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Overall Study STARTED	19	18
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thrombelastography (TEG) Guided n=19 Participants Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69 Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder	Light Transmittance Aggregometry Guided n=18 Participants Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9% Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder	Total n=37 Participants Total of all reporting groups
Age, Continuous	55.2 years STANDARD_DEVIATION 9.8 • n=5 Participants	53.2 years STANDARD_DEVIATION 10.5 • n=7 Participants	54.2 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: TEG-MA (mm) at 16-24 hours outcome measure

Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel

Outcome measures

Outcome measures
Measure	Thrombelastography (TEG) Guided n=19 Participants Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69 Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder	Light Transmittance Aggregometry Guided n=18 Participants Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9% Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Thrombelastography (TEG) MA	66.4 mm Standard Deviation 11	65.8 mm Standard Deviation 6.9

SECONDARY outcome

Timeframe: 6 months

Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention

Outcome measures

Outcome measures
Measure	Thrombelastography (TEG) Guided n=19 Participants Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69 Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder	Light Transmittance Aggregometry Guided n=18 Participants Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9% Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Number of Participants With Ischemic Events Unstable Angina · No Event	17 Participants	16 Participants
Number of Participants With Ischemic Events Death · Event	0 Participants	0 Participants
Number of Participants With Ischemic Events Death · No Event	19 Participants	18 Participants
Number of Participants With Ischemic Events Myocardial Infarction · Event	1 Participants	0 Participants
Number of Participants With Ischemic Events Myocardial Infarction · No Event	18 Participants	18 Participants
Number of Participants With Ischemic Events Recurrent coronary intervention · Event	3 Participants	2 Participants
Number of Participants With Ischemic Events Recurrent coronary intervention · No Event	16 Participants	16 Participants
Number of Participants With Ischemic Events Unstable Angina · Event	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

Major or Minor Bleeding according to TIMI criteria

Outcome measures

Outcome measures
Measure	Thrombelastography (TEG) Guided n=19 Participants Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA\<69 Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder	Light Transmittance Aggregometry Guided n=18 Participants Clopidogrel non-response defined as MPA ADP \>42.9% Clopidogrel response defined as MPA ADP \<42.9% Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Number of Participants With Bleeding Events Bleeding	0 Participants	0 Participants
Number of Participants With Bleeding Events No Bleeding	19 Participants	18 Participants

Adverse Events

Thrombelastography (TEG) Guided

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Light Transmittance Aggregometry Guided

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rolf Kreutz, MD

Indiana University School of Medicine

Phone: 3179620500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place