Trial Outcomes & Findings for Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (NCT NCT02406677)

NCT ID: NCT02406677

Last Updated: 2019-10-01

Results Overview

To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11001 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-10-01

Participant Flow

Study recruited patients on P2Y12 inhibitor therapy with US-based health insurance. Recruitment into 301 study sites (hospitals) in the US was conducted from June, 2015 to September, 2016. The study evaluated whether patient copayment reduction significantly influenced antiplatelet therapy selection and long-term adherence.

The study population included patients STEMI or NSTEMI who were treated with a P2Y12 receptor inhibitor. After patient enrollment into hospitals, each hospital was randomized into either the intervention or the control arm (cluster randomization). The randomization scheme was changed from 1:1 to 2:1 mid-study. 12 month study duration.

Participant milestones

Measure	Copayment Intervention Arm Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.	Usual Care Arm For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
Overall Study STARTED	6436	4565
Overall Study COMPLETED	6135	3967
Overall Study NOT COMPLETED	301	598

Reasons for withdrawal

Measure	Copayment Intervention Arm Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.	Usual Care Arm For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.
Overall Study Death	16	8
Overall Study Discharged without P2Y12	1	3
Overall Study Discharged on prasugrel	283	587
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Primary Population

Baseline characteristics by cohort

Measure	Copayment Intervention Arm n=6135 Participants Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.	Usual Care Arm n=3967 Participants For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.	Total n=10102 Participants Total of all reporting groups
Age, Continuous Age	62.08 Years STANDARD_DEVIATION 11.78 • n=5 Participants • Primary Population	62.10 Years STANDARD_DEVIATION 11.55 • n=7 Participants • Primary Population	62.09 Years STANDARD_DEVIATION 11.69 • n=5 Participants • Primary Population
Sex: Female, Male Female	1942 Participants n=5 Participants • Primary Population	1285 Participants n=7 Participants • Primary Population	3227 Participants n=5 Participants • Primary Population
Sex: Female, Male Male	4193 Participants n=5 Participants • Primary Population	2682 Participants n=7 Participants • Primary Population	6875 Participants n=5 Participants • Primary Population
Ethnicity (NIH/OMB) Hispanic or Latino	188 Participants n=5 Participants • Primary Population	222 Participants n=7 Participants • Primary Population	410 Participants n=5 Participants • Primary Population
Ethnicity (NIH/OMB) Not Hispanic or Latino	5947 Participants n=5 Participants • Primary Population	3745 Participants n=7 Participants • Primary Population	9692 Participants n=5 Participants • Primary Population
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Primary Population	0 Participants n=7 Participants • Primary Population	0 Participants n=5 Participants • Primary Population
Race/Ethnicity, Customized Race · White	5495 Participants n=5 Participants	3416 Participants n=7 Participants	8911 Participants n=5 Participants
Race/Ethnicity, Customized Race · Non-White	640 Participants n=5 Participants	551 Participants n=7 Participants	1191 Participants n=5 Participants
Insurance Payors - Private Health Insurance	3864 Participants n=5 Participants • Primary Population	2540 Participants n=7 Participants • Primary Population	6404 Participants n=5 Participants • Primary Population

PRIMARY outcome

Timeframe: 12 months

Population: Primary Population

To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.

Outcome measures

Measure	Copayment Intervention Arm n=6135 Participants Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.	Usual Care Arm n=3967 Participants For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.	Usual Care Arm - Clopidogrel Patients in the Usual Care Arm discharged on Clopidogrel	Usual Care Arm - Ticagrelor Patients in the Usual Care Arm discharged on Ticagrelor
Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events	10.17 Percentage of Participants Interval 9.4 to 10.93	10.93 Percentage of Participants Interval 9.67 to 11.6	—	—

PRIMARY outcome

Timeframe: 12 months

Population: Primary Population

To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.

Outcome measures

Measure	Copayment Intervention Arm n=6135 Participants Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.	Usual Care Arm n=3967 Participants For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.	Usual Care Arm - Clopidogrel Patients in the Usual Care Arm discharged on Clopidogrel	Usual Care Arm - Ticagrelor Patients in the Usual Care Arm discharged on Ticagrelor
Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor	12.96 Percentage of Patients	16.21 Percentage of Patients	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Primary Population

To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.

Outcome measures

Measure	Copayment Intervention Arm n=6135 Participants Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.	Usual Care Arm n=6135 Participants For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.	Usual Care Arm - Clopidogrel n=3967 Participants Patients in the Usual Care Arm discharged on Clopidogrel	Usual Care Arm - Ticagrelor n=3967 Participants Patients in the Usual Care Arm discharged on Ticagrelor
P2Y12 Receptor Inhibitor Selection	36.0 Percentage of Patients	59.6 Percentage of Patients	54.7 Percentage of Patients	32.4 Percentage of Patients

Adverse Events

Copayment Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 16 deaths

Usual Care Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Naeem Khan, MD, VP, CVMD TA

AstraZeneca Pharmaceuticals LP

Phone: 302-886-5526

Email: Naeem.Khan@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee Registry Site shall submit to the Committee for its review a copy of any proposed publication resulting from the Registry at least thirty (30) days prior to the date of submission for publication or at least fifteen (15) days prior to submission for an abstract, and if no response is received within sixty (60) days of the date submitted to Sponsor, it will be conclusively presumed that the publication may proceed without delay.
• Publication restrictions are in place

Restriction type: OTHER