Trial Outcomes & Findings for Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients (NCT NCT00257309)

NCT ID: NCT00257309

Last Updated: 2017-01-19

Results Overview

Incidence of all-cause death or myocardial reinfarction or disabling stroke

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 266 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2017-01-19

Participant Flow

Participant milestones

Measure	Thrombolysis Weight adjusted tenecteplase bolus + Unfrationated heparin Tenecteplase + UFH (+ clopidogrel, since 01/97)	Primary Angioplasty Primary angioplasty Primary angioplasty
Overall Study STARTED	134	132
Overall Study COMPLETED	132	130
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients

Baseline characteristics by cohort

Measure	Thrombolysis n=134 Participants Weight adjusted tenecteplase bolus + Unfrationated heparin Tenecteplase + UFH (+ clopidogrel, since 01/97)	Primary Angioplasty n=132 Participants Primary angioplasty Primary angioplasty	Total n=266 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	134 Participants n=5 Participants	132 Participants n=7 Participants	266 Participants n=5 Participants
Age, Continuous	81.0 years STANDARD_DEVIATION 4.3 • n=5 Participants	81.2 years STANDARD_DEVIATION 4.6 • n=7 Participants	81.1 years STANDARD_DEVIATION 4.5 • n=5 Participants
Gender Female	76 Participants n=5 Participants	74 Participants n=7 Participants	150 Participants n=5 Participants
Gender Male	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Region of Enrollment Spain	134 participants n=5 Participants	132 participants n=7 Participants	266 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Incidence of all-cause death or myocardial reinfarction or disabling stroke

Outcome measures

Measure	Thrombolysis n=134 Participants Weight adjusted tenecteplase bolus + Unfrationated heparin Tenecteplase + UFH (+ clopidogrel, since 01/97)	Primary Angioplasty n=132 Participants Primary angioplasty Primary angioplasty
Incidence of Death or Reinfarction or Disabling Stroke	34 participants	25 participants

PRIMARY outcome

Timeframe: 30 days

Incidence of Death or Reinfarction or Disabling Stroke at 30 days

Outcome measures

Measure	Thrombolysis n=134 Participants Weight adjusted tenecteplase bolus + Unfrationated heparin Tenecteplase + UFH (+ clopidogrel, since 01/97)	Primary Angioplasty n=132 Participants Primary angioplasty Primary angioplasty
Death/Reinfarction/Disabling Stroke at 30 Days	34 Participants	25 Participants

Adverse Events

Thrombolysis

Serious events: 16 serious events

Other events: 8 other events

Deaths: 0 deaths

Primary Angioplasty

Serious events: 13 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Thrombolysis n=134 participants at risk Weight adjusted tenecteplase bolus + Unfrationated heparin Tenecteplase + UFH (+ clopidogrel, since 01/97)	Primary Angioplasty n=132 participants at risk Primary angioplasty Primary angioplasty
Blood and lymphatic system disorders Major bleeding	3.7% 5/134 • Number of events 5	4.5% 6/132 • Number of events 6
Cardiac disorders Mechanical complications	3.0% 4/134 • Number of events 4	3.0% 4/132 • Number of events 4
Blood and lymphatic system disorders Red blood transfusion	5.2% 7/134 • Number of events 7	3.0% 4/132 • Number of events 4
Blood and lymphatic system disorders Major hemorrhage or transfusion	9.0% 12/134 • Number of events 12	6.8% 9/132 • Number of events 9

Other adverse events

Measure	Thrombolysis n=134 participants at risk Weight adjusted tenecteplase bolus + Unfrationated heparin Tenecteplase + UFH (+ clopidogrel, since 01/97)	Primary Angioplasty n=132 participants at risk Primary angioplasty Primary angioplasty
Renal and urinary disorders Acute renal failure	6.0% 8/134 • Number of events 8	7.6% 10/132 • Number of events 10

Additional Information

Héctor Bueno

Centro Nacional de Investigaciones Cardiovasculares

Phone: (+34) 914 531 200

Email: hbueno@cnic.es

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place