Trial Outcomes & Findings for STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction (NCT NCT02777580)
NCT ID: NCT02777580
Last Updated: 2024-10-04
Results Overview
Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
609 participants
Primary outcome timeframe
30 min post angiogram/PCI
Results posted on
2024-10-04
Participant Flow
Participant milestones
| Measure |
Pharmaco-invasive Strategy
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Tenecteplase: Half dose Tenecteplase
Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required
|
Standard Primary PCI
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Primary PCI: Primary PCI accoring to local standards
|
|---|---|---|
|
Overall Study
STARTED
|
405
|
204
|
|
Overall Study
COMPLETED
|
401
|
203
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pharmaco-invasive Strategy
n=401 Participants
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Tenecteplase: Half dose Tenecteplase
Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required
|
Standard Primary PCI
n=203 Participants
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Primary PCI: Primary PCI accoring to local standards
|
Total
n=604 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=401 Participants
|
0 Participants
n=203 Participants
|
0 Participants
n=604 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
113 Participants
n=401 Participants
|
47 Participants
n=203 Participants
|
160 Participants
n=604 Participants
|
|
Age, Categorical
>=65 years
|
288 Participants
n=401 Participants
|
156 Participants
n=203 Participants
|
444 Participants
n=604 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 8 • n=401 Participants
|
71 years
STANDARD_DEVIATION 8 • n=203 Participants
|
70 years
STANDARD_DEVIATION 8 • n=604 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=401 Participants
|
66 Participants
n=203 Participants
|
197 Participants
n=604 Participants
|
|
Sex: Female, Male
Male
|
270 Participants
n=401 Participants
|
137 Participants
n=203 Participants
|
407 Participants
n=604 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
66 participants
n=401 Participants
|
34 participants
n=203 Participants
|
100 participants
n=604 Participants
|
|
Region of Enrollment
Brazil
|
14 participants
n=401 Participants
|
6 participants
n=203 Participants
|
20 participants
n=604 Participants
|
|
Region of Enrollment
Mexico
|
53 participants
n=401 Participants
|
28 participants
n=203 Participants
|
81 participants
n=604 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=401 Participants
|
3 participants
n=203 Participants
|
9 participants
n=604 Participants
|
|
Region of Enrollment
Chile
|
10 participants
n=401 Participants
|
5 participants
n=203 Participants
|
15 participants
n=604 Participants
|
|
Region of Enrollment
France
|
28 participants
n=401 Participants
|
14 participants
n=203 Participants
|
42 participants
n=604 Participants
|
|
Region of Enrollment
Serbia
|
117 participants
n=401 Participants
|
60 participants
n=203 Participants
|
177 participants
n=604 Participants
|
|
Region of Enrollment
Montenegro
|
5 participants
n=401 Participants
|
3 participants
n=203 Participants
|
8 participants
n=604 Participants
|
|
Region of Enrollment
Russia
|
95 participants
n=401 Participants
|
47 participants
n=203 Participants
|
142 participants
n=604 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=401 Participants
|
3 participants
n=203 Participants
|
10 participants
n=604 Participants
|
PRIMARY outcome
Timeframe: 30 min post angiogram/PCIWorst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI
Outcome measures
| Measure |
Pharmaco-invasive Strategy
n=358 Participants
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Tenecteplase: Half dose Tenecteplase
Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required
|
Standard Primary PCI
n=190 Participants
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Primary PCI: Primary PCI accoring to local standards
|
|---|---|---|
|
Successful Reperfusion
|
305 Participants
|
149 Participants
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Pharmaco-invasive Strategy
n=401 Participants
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Tenecteplase: Half dose Tenecteplase
Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required
|
Standard Primary PCI
n=203 Participants
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Primary PCI: Primary PCI accoring to local standards
|
|---|---|---|
|
Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days
|
51 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 30 daysNumber of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion)
Outcome measures
| Measure |
Pharmaco-invasive Strategy
n=400 Participants
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Tenecteplase: Half dose Tenecteplase
Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required
|
Standard Primary PCI
n=203 Participants
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Primary PCI: Primary PCI accoring to local standards
|
|---|---|---|
|
Total Stroke
|
9 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Pharmaco-invasive Strategy
n=401 Participants
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Tenecteplase: Half dose Tenecteplase
Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required
|
Standard Primary PCI
n=203 Participants
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Primary PCI: Primary PCI accoring to local standards
|
|---|---|---|
|
Major Non-intrancranial Bleedings
|
5 Participants
|
2 Participants
|
Adverse Events
Pharmaco-invasive Strategy
Serious events: 69 serious events
Other events: 0 other events
Deaths: 37 deaths
Standard Primary PCI
Serious events: 32 serious events
Other events: 0 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Pharmaco-invasive Strategy
n=401 participants at risk
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Tenecteplase: Half dose Tenecteplase
Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required
|
Standard Primary PCI
n=203 participants at risk
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Primary PCI: Primary PCI accoring to local standards
|
|---|---|---|
|
Cardiac disorders
cardiogenic shock
|
4.5%
18/400 • 30 days
|
5.4%
11/203 • 30 days
|
|
Cardiac disorders
heart failure
|
3.5%
14/400 • 30 days
|
4.4%
9/203 • 30 days
|
|
Cardiac disorders
reinfarction
|
2.5%
10/400 • 30 days
|
2.5%
5/203 • 30 days
|
|
Nervous system disorders
intracranial hemorrhage
|
1.5%
6/400 • 30 days
|
0.00%
0/203 • 30 days
|
|
Nervous system disorders
ischemic stroke
|
0.75%
3/400 • 30 days
|
0.49%
1/203 • 30 days
|
|
Vascular disorders
major nonintracranial bleeding
|
1.2%
5/400 • 30 days
|
0.99%
2/203 • 30 days
|
|
Cardiac disorders
acute ventricle septum defect
|
0.75%
3/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Cardiac disorders
coronary arterial dissection
|
0.00%
0/401 • 30 days
|
0.99%
2/203 • 30 days
|
|
Cardiac disorders
atrial fibrillation
|
0.75%
3/401 • 30 days
|
0.99%
2/203 • 30 days
|
|
Cardiac disorders
Bradycardia
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Cardiac disorders
cardiac arrest
|
0.25%
1/401 • 30 days
|
0.99%
2/203 • 30 days
|
|
Cardiac disorders
cardiac failure
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Cardiac disorders
myocardial rupture
|
1.7%
7/401 • 30 days
|
0.49%
1/203 • 30 days
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/401 • 30 days
|
0.49%
1/203 • 30 days
|
|
Cardiac disorders
pulseless electrical activity
|
0.25%
1/401 • 30 days
|
0.99%
2/203 • 30 days
|
|
Cardiac disorders
sudden death
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Cardiac disorders
ventricle rupture
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Cardiac disorders
ventricular asystole
|
0.00%
0/401 • 30 days
|
0.49%
1/203 • 30 days
|
|
Cardiac disorders
ventricular tachycardia
|
1.00%
4/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Cardiac disorders
ventricular fibrillation
|
1.00%
4/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Cardiac disorders
Chest pain
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Cardiac disorders
right venticular failure
|
0.00%
0/401 • 30 days
|
0.49%
1/203 • 30 days
|
|
General disorders
Death
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
General disorders
Systemic inflammatory response syndrome
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
General disorders
Vascular stent thrombosis
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Infections and infestations
COVID-19
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Infections and infestations
Infection
|
0.25%
1/401 • 30 days
|
0.49%
1/203 • 30 days
|
|
Infections and infestations
Pneumonia
|
1.00%
4/401 • 30 days
|
0.99%
2/203 • 30 days
|
|
Metabolism and nutrition disorders
Gout
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/401 • 30 days
|
0.49%
1/203 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.25%
1/401 • 30 days
|
0.00%
0/203 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumotorax
|
0.00%
0/401 • 30 days
|
0.49%
1/203 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60